Aung Naing, MD, FACP

Peer-Reviewed Articles

1. Piha-Paul, SA, Tseng, C, Leung, CH, Yuan, Y, Karp, DD, Subbiah, V, Hong, DS, Fu, S, Naing, A, Rodon Ahnert, J, Javle, M, Ajani, JA, Raghav, KS, Somaiah, N, Mills, GB, Tsimberidou, AM, Zheng, X, Chen, K, Meric-Bernstam, F. Phase II study of talazoparib in advanced cancers with BRCA1/2, DNA repair, and PTEN alterations. npj Precision Oncology 8(1), 2024. e-Pub 2024. PMID: 39085400.
2. Gouda, MA, Shunyakova, J, Naing, A, Ileana Dumbrava, EE, Hong, DS, Yuan, Y, Yang, P, Myers, AL, Liang, Y, Peng, J, Karp, DD, Tsimberidou, AM, Rodon Ahnert, J, Yap, TA, Piha-Paul, SA, Meric-Bernstam, F, Fu, S. A phase I study of TAK-659 and paclitaxel in patients with taxane-refractory advanced solid tumors. ESMO Open 9(6), 2024. e-Pub 2024. PMID: 38914452.
3. Coleman, N, Stephen, B, Fu, S, Karp, DD, Subbiah, V, Rodon Ahnert, J, Piha-Paul, SA, Wright, J, Fessahaye, SN, Ouyang, F, Yilmaz, B, Meric-Bernstam, F, Naing, A. Phase I study of sapanisertib (CB-228/TAK-228/MLN0128) in combination with ziv-aflibercept in patients with advanced solid tumors. Cancer medicine 13(3), 2024. e-Pub 2024. PMID: 38400671.
4. Knisely, A, Ahmed, J, Stephen, B, Piha-Paul, SA, Karp, DD, Zarifa, A, Fu, S, Hong, DS, Rodon Ahnert, J, Yap, TA, Tsimberidou, AM, Alshawa, A, Ileana Dumbrava, EE, Yang, Y, Song, J, Meric-Bernstam, F, Jazaeri, AA, Naing, A. Phase 1/2 trial of avelumab combined with utomilumab (4-1BB agonist), PF-04518600 (OX40 agonist), or radiotherapy in patients with advanced gynecologic malignancies. Cancer 130(3):400-409, 2024. e-Pub 2024. PMID: 37864520.
5. Altan M, Soto F, Xu T, Wilson N, Franco-Vega MC, Simbaqueba Clavijo CA, Shannon VR, Faiz SA, Gandhi S, Lin SH, Lopez P, Zhong L, Akhmedzhanov F, Godoy MCB, Shroff GS, Wu J, Khawaja F, Kim ST, Naing A, Heymach JV, Daniel-Macdougall C, Liao Z, Sheshadri A. Pneumonitis After Concurrent Chemoradiation and Immune Checkpoint Inhibition in Patients with Locally Advanced Non-small Cell Lung Cancer. Clin Oncol (R Coll Radiol) 35(10):630-639, 2023. e-Pub 2023. PMID: 37507279.
6. Altan M, Tu J, Milton DR, Yilmaz B, Tian Y, Fossella FV, Mott FE, Blumenschein GR, Stephen B, Karp DD, Meric-Bernstam F, Heymach JV, Naing A. Safety, tolerability, and clinical activity of selinexor in combination with pembrolizumab in treatment of metastatic non-small cell lung cancer. Cancer 129(17):2685-2693, 2023. e-Pub 2023. PMID: 37129197.
7. Hajjar J, Derbala MH, Naing A. Unlocking the Potential of Anti-TIGIT Therapy-Between Promise and Challenges. JAMA Oncol. e-Pub 2023. PMID: 37768657.
8. Yibirin M, Mustafayev K, Hosry J, Pundhir P, Klingen J, Yepez Guevara E, Granwehr BP, Kaseb A, Naing A, Patel S, Shah AY, Skoulidis F, Tawbi HA, Wang L, Miller E, Zhang HC, Zurita-Saavedra A, Torres HA. Immune Checkpoint Inhibitors Suppress Hepatitis C Virus Replication in Infected Patients With Solid Tumors. Am J Gastroenterol 118(9):1609-1617, 2023. e-Pub 2023. PMID: 37307533.
9. Nardo M, Yilmaz B, Nelson BE, Torres HA, Wang LS, Granwehr BP, Song J, Dalla Pria HRF, Trinh VA, Glitza Oliva IC, Patel SP, Tannir NM, Kaseb AO, Altan M, Lee SS, Miller E, Zhang H, Stephen BA, Naing A. Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Cancer and Viral Hepatitis: The MD Anderson Cancer Center Experience. Oncologist 28(8):714-721, 2023. e-Pub 2023. PMID: 36952233.
10. Stephen B, Hajjar J, Sarda S, Duose DY, Conroy JM, Morrison C, Alshawa A, Xu M, Zarifa A, Patel SP, Yuan Y, Kwiatkowski E, Wang L, Rodon Ahnert J, Fu S, Meric-Bernstam F, Lowman GM, Looney T, Naing A. T-cell receptor beta variable gene polymorphism predicts immune-related adverse events during checkpoint blockade immunotherapy. J Immunother Cancer 11(8), 2023. e-Pub 2023. PMID: 37604642.
11. Nelson BE, Saleem S, Damodaran S, Somaiah N, Piha-Paul S, Moore JA, Yilmaz B, Ogbonna D, Karp DD, Dumbrava E, Tsimberidou AM, Hong DS, Rodon Ahnert J, Milton DR, Zheng X, Booser DJ, Ibrahim NK, Conley AP, Bhosale P, Rojas Hernandez CM, Tripathy D, Naing A, Meric-Bernstam F. Phase 1b study of combined selinexor and eribulin for the treatment of advanced solid tumors and triple-negative breast cancer. Cancer 129(14):2201-2213, 2023. e-Pub 2023. PMID: 37016732.
12. Nze C, Msaouel P, Derbala MH, Stephen B, Abonofal A, Meric-Bernstam F, Tannir NM, Naing A. A Phase II Clinical Trial of Pembrolizumab Efficacy and Safety in Advanced Renal Medullary Carcinoma. Cancers (Basel) 15(15), 2023. e-Pub 2023. PMID: 37568622.
13. Luke JJ, Fakih M, Schneider C, Chiorean EG, Bendell J, Kristeleit R, Kurzrock R, Blagden SP, Brana I, Goff LW, O'Hayer K, Geschwindt R, Smith M, Zhou F, Naing A. Phase I/II sequencing study of azacitidine, epacadostat, and pembrolizumab in advanced solid tumors. Br J Cancer 128(12):2227-2235, 2023. e-Pub 2023. PMID: 37087488.
14. Ameri M, Al Zubidi N, Razmandi A, Whyte A, Naing A, Patel NA, Gombos DS. Ocular Toxicity Profile of Targeted Cancer Therapy (TCT) at a US Tertiary Cancer Center. Cureus 15(6):e40597, 2023. e-Pub 2023. PMID: 37347077.
15. Altan M, Soto F, Zhong LL, Akhmedzhanov FO, Wilson NR, Zarifa A, Albittar AA, Yang V, Lewis J, Rinsurongkawong W, Jack Lee J, Rinsurongkawong V, Zhang J, Gibbons DL, Vaporciyan AA, Jennings K, Khawaja F, Faiz SA, Shannon VR, Shroff G, Godoy MCB, Daver NG, Gandhi S, Mendoza TR, Naing A, Daniel-MacDougall C, Heymach JV, Sheshadri A. Incidence and Risk Factors for Pneumonitis Associated With Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer: A Single Center Experience. Oncologist. e-Pub 2023. PMID: 37156009.
16. Carmagnani Pestana R, Moyers JT, Roszik J, Sen S, Hong DS, Naing A, Herzog CE, Fu S, Piha-Paul SA, Rodon J, Yap TA, Karp DD, Tsimberidou AM, Pant S, Zarzour MA, Ratan R, Ravi V, Benjamin RS, Lazar AJ, Wang WL, Daw N, Gill JB, Harrison DJ, Lewis VO, Roland CL, Patel SR, Livingston JA, Somaiah N, Ludwig JA, Conley AP, Hamerschlak N, Gorlick R, Meric-Bernstam F, Subbiah V. Impact of Biomarker-Matched Therapies on Outcomes in Patients with Sarcoma Enrolled in Early-Phase Clinical Trials (SAMBA 101). Clin Cancer Res 29(9):1708-1718, 2023. e-Pub 2023. PMID: 37058010.
17. Surana R, Gonzalez GN, Rogers J, Hong DS, Yap TA, Rodon J, Naing A, Wolff RA, Smaglo BG, Bernstam FM, Subbiah V, Pant S. Utility of Established Prognostic Scoring Systems for Patients with Advanced Pancreatic Adenocarcinoma Enrolled in Immunotherapy-Based Early-Phase Clinical Trials. J Gastrointest Cancer. e-Pub 2023. PMID: 37119430.
18. Son J, Lin HY, Fu S, Biter AB, Dumbrava EE, Karp DD, Naing A, Pant S, Piha-Paul SA, Rodon J, Subbiah V, Tsimberidou AM, Yap TA, Frumovitz MM, Jazaeri AA, Ramirez PT, Westin SN, Yuan Y, Meric-Bernstam F, Hong DS. Predictors of Oncologic Outcome in Patients Receiving Phase I Investigational Therapy for Recurrent or Metastatic Cervical Cancer. J Immunother Precis Oncol 6(1):10-18, 2023. e-Pub 2023. PMID: 36751659.
19. Nelson BE, Roszik J, Janku F, Hong DS, Kato S, Naing A, Piha-Paul S, Fu S, Tsimberidou A, Cabanillas M, Busaidy NL, Javle M, Byers LA, Heymach JV, Meric-Bernstam F, Subbiah V. BRAF v600E-mutant cancers treated with vemurafenib alone or in combination with everolimus, sorafenib, or crizotinib or with paclitaxel and carboplatin (VEM-PLUS) study. NPJ Precis Oncol 7(1):19, 2023. e-Pub 2023. PMID: 36801912.
20. de Miguel-Perez D, Russo A, Gunasekaran M, Buemi F, Hester L, Fan X, Carter-Cooper BA, Lapidus RG, Peleg A, Arroyo-Hernández M, Cardona AF, Naing A, Hirsch FR, Mack PC, Kaushal S, Serrano MJ, Adamo V, Arrieta O, Rolfo C. Baseline extracellular vesicle TGF-β is a predictive biomarker for response to immune checkpoint inhibitors and survival in non-small cell lung cancer. Cancer 129(4):521-530, 2023. e-Pub 2023. PMID: 36484171.
21. Naing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer 129(1):71-81, 2023. e-Pub 2023. PMID: 36309837.
22. Yap TA, Daver N, Mahendra M, Zhang J, Kamiya-Matsuoka C, Meric-Bernstam F, Kantarjian HM, Ravandi F, Collins ME, Francesco MED, Dumbrava EE, Fu S, Gao S, Gay JP, Gera S, Han J, Hong DS, Jabbour EJ, Ju Z, Karp DD, Lodi A, Molina JR, Baran N, Naing A, Ohanian M, Pant S, Pemmaraju N, Bose P, Piha-Paul SA, Rodon J, Salguero C, Sasaki K, Singh AK, Subbiah V, Tsimberidou AM, Xu QA, Yilmaz M, Zhang Q, Li Y, Bristow CA, Bhattacharjee MB, Tiziani S, Heffernan TP, Vellano CP, Jones P, Heijnen CJ, Kavelaars A, Marszalek JR, Konopleva M. Complex I inhibitor of oxidative phosphorylation in advanced solid tumors and acute myeloid leukemia: phase I trials. Nat Med 29(1):115-126, 2023. e-Pub 2023. PMID: 36658425.
23. Moyers JT, Pestana RC, Roszik J, Hong DS, Naing A, Fu S, Piha-Paul S, Yap TA, Karp D, Rodon J, Livingston A, Zarzour MA, Ravi V, Patel S, Benjamin RS, Ludwig J, Herzog C, Ratan R, Somaiah N, Conley A, Gorlick R, Meric-Bernstam F, Subbiah V. Examining Stripes on a Herd of Zebras: Impact of Genomic Matching for Ultrarare Sarcomas in Phase 1 Clinical Trials (SAMBA 102). Clin Cancer Res 29(2):401-409, 2023. e-Pub 2023. PMID: 36288393.
24. Westin SN, Fu S, Tsimberidou A, Piha-Paul S, Akhmedzhanov F, Yilmaz B, McQuinn L, Brink AL, Gong J, Leung CH, Lin H, Hong DS, Pant S, Carter B, Jazaeri A, Gershenson D, Sood AK, Coleman RL, Shah J, Meric-Bernstam F, Naing A. Selinexor in combination with weekly paclitaxel in patients with metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study with expansion phase in ovarian cancer. Gynecol Oncol 168:76-82, 2023. e-Pub 2023. PMID: 36423446.
25. Powderly JD, Klempner SJ, Naing A, Bendell J, Garrido-Laguna I, Catenacci DVT, Taylor MH, Lee JJ, Zheng F, Zhou F, Gong X, Gowda H, Beatty GL. Epacadostat Plus Pembrolizumab and Chemotherapy for Advanced Solid Tumors: Results from the Phase I/II ECHO-207/KEYNOTE-723 Study. Oncologist 27(11):905-e848, 2022. e-Pub 2022. PMID: 36156099.
26. Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul S, Subbiah V, Janku F, Naing A, Yap TA, Rodon J, Ajani JA, Cartwright C, Johnson A, Song IW, Beck J, Kahle M, Nogueras-Gonzalez GM, Miller V, Chao C, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. NPJ Precis Oncol 6(1):78, 2022. e-Pub 2022. PMID: 36302890.
27. Short NJ, Borthakur G, Pemmaraju N, Dinardo CD, Kadia TM, Jabbour E, Konopleva M, Macaron W, Ning J, Ma J, Pierce S, Alvarado Y, Sasaki K, Takahashi K, Estrov Z, Masarova L, Issa GC, Montalban-Bravo G, Andreeff M, Burger JA, Miller D, Alexander L, Naing A, Garcia-Manero G, Ravandi F, Daver N. A multi-arm phase Ib/II study designed for rapid, parallel evaluation of novel immunotherapy combinations in relapsed/refractory acute myeloid leukemia. Leuk Lymphoma 63(9):2161-2170, 2022. e-Pub 2022. PMID: 35442137.
28. Ravi V, Subramaniam A, Zheng J, Amini B, Trinh VA, Joseph J, Mennel RG, Bishop AJ, Sturgis EM, Goepfert RP, Yalamanchili S, Botello G, Stephen B, Piha-Paul SA, Patel AB, Lazar AJ, Conley AP, Benjamin RS, Patel SR, Futreal PA, Somaiah N, Naing A. Clinical activity of checkpoint inhibitors in angiosarcoma: A retrospective cohort study. Cancer 128(18):3383-3391, 2022. e-Pub 2022. PMID: 35792683.
29. Mendoza TR, Hong DS, Peterson CB, Stephen B, Dumbrava E, Pant S, Tsimberidou AM, Yap TA, Sheshadri A, Altan M, George G, Castillo L, Rodriguez E, Gong J, Subbiah V, Janku F, Fu S, Piha-Paul SA, Ahnert JR, Karp DD, Cleeland C, Meric-Bernstam F, Naing A. Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial. Sci Rep 12(1):14367, 2022. e-Pub 2022. PMID: 35999229.
30. Gouda MA, Huang HJ, Piha-Paul SA, Call SG, Karp DD, Fu S, Naing A, Subbiah V, Pant S, Dustin DJ, Tsimberidou AM, Hong DS, Rodon J, Meric-Bernstam F, Janku F. Longitudinal Monitoring of Circulating Tumor DNA to Predict Treatment Outcomes in Advanced Cancers. JCO Precis Oncol 6:e2100512, 2022. e-Pub 2022. PMID: 35834760.
31. How JA, Jazaeri AA, Fu S, Rodon Ahnert J, Gong J, Stephen B, Ferreira Dalla Pria H, Bhosale P, Johnson A, Yuan Y, Meric-Bernstam F, Naing A. Clinical Outcomes of Patients with Recurrent Microsatellite-Stable Endometrial Cancer in Early-Phase Immunotherapy Clinical Trials. Cancers (Basel) 14(15), 2022. e-Pub 2022. PMID: 35954359.
32. de Miguel-Perez D, Russo A, Arrieta O, Ak M, Barron F, Gunasekaran M, Mamindla P, Lara-Mejia L, Peterson CB, Er ME, Peddagangireddy V, Buemi F, Cooper B, Manca P, Lapidus RG, Hsia RC, Cardona AF, Naing A, Kaushal S, Hirsch FR, Mack PC, Serrano MJ, Adamo V, Colen RR, Rolfo C. Extracellular vesicle PD-L1 dynamics predict durable response to immune-checkpoint inhibitors and survival in patients with non-small cell lung cancer. J Exp Clin Cancer Res 41(1):186, 2022. e-Pub 2022. PMID: 35650597.
33. Raghav KP, Stephen B, Karp DD, Piha-Paul SA, Hong DS, Jain D, Chudy Onwugaje DO, Abonofal A, Willett AF, Overman M, Smaglo B, Huey RW, Meric-Bernstam F, Varadhachary GR, Naing A. Efficacy of pembrolizumab in patients with advanced cancer of unknown primary (CUP): a phase 2 non-randomized clinical trial. J Immunother Cancer 10(5), 2022. e-Pub 2022. PMID: 35618285.
34. Daher M, Varghese J, Gruschkus SK, Jimenez C, Waguespack SG, Bedrose S, Altameemi L, Bazerbashi H, Naing A, Subaiah V, Campbell MT, Shah AY, Zhang M, Sheth RA, Karam JA, Wood CG, Perrier ND, Graham PH, Lee JE, Habra MA. Temporal Trends in Outcomes in Patients With Adrenocortical Carcinoma: A Multidisciplinary Referral-center Experience. J Clin Endocrinol Metab 107(5):1239-1246, 2022. e-Pub 2022. PMID: 35092681.
35. Thein KZ, Fu S, Janku F, Tsimberidou AM, Piha-Paul SA, Karp DD, Shah J, Milton DR, Gong J, Sulovic S, McQuinn L, Stephen BA, Colen RR, Carter BW, Meric-Bernstam F, Naing A. Selinexor in Combination with Carboplatin and Pemetrexed in Patients with Advanced or Metastatic Solid Tumors: Results of an Open-Label, Single-Center, Multi-Arm Phase 1b Study. J Immunother Precis Oncol 5(1):10-12, 2022. e-Pub 2022. PMID: 35663832.
36. Alhalabi O, Hahn AW, Msaouel P, Meric-Bernstam F, Wilson N, Naing A, Piha-Paul S, Janku F, Pant S, Yap TA, Hong DS, Fu S, Karp D, Beltran K, Campbell E, Le H, Campbell MT, Shah A, Tannir NM, Siefker-Radtke A, Gao J, Roszik J, Subbiah V. Validation of Prognostic Scores in Patients With Metastatic Urothelial Cancer Enrolling in Phase I Targeted Therapy or Next Generation Immunotherapy Trials. Clin Genitourin Cancer 20(1):e16-e24, 2022. e-Pub 2022. PMID: 34362693.
37. Dev R, Zhong LL, Zarifa A, Albittar AA, Rubin L, Liu S, Yap TA, Dalal S, Hui D, Karp DD, Tsimberidou AM, Piha-Paul SA, Ahnert JR, Fu S, Meric-Bernstam F, Naing A. Supportive care for the prevention of nausea, vomiting and anorexia in a phase 1B study of selinexor in advanced cancer patients: an exploratory study. Invest New Drugs 40(1):124-133, 2022. e-Pub 2022. PMID: 34559346.
38. Naing A, Pwderly JD, Nemunaitis JJ, Luke JJ, Mansfield AS, Messersmith WA, Sahebjam S, LoRusso PM, Garrido-Laguna I, Leopold L, Geschwindt R, Ding K, Smith M, Berlin JD. Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study. J Immunother Cancer 10(3):e004223, 2022. e-Pub 2022. PMID: 35288468.
39. Kim ST, Chu Y, Misoi M, Saurez-Almazor ME, Tayar JH, Lu H, Buni M, Kramer J, Rodriguez E, Hussain Z, Neelapu SS, Wang J, Shah AY, Tannir NM, Campbell MT, Gibbons DL, Cascone T, Lu C, Blumenschein GR, Altan M, Lim B, Valero V, Loghin ME, Tu J, Westin SN, Naing A, Garcia-Manero G, Abdel-Wahab N, Tawbi HA, Hwu P, Glitza Oliva IC, Davies MA, Patel SP, Zou J, Fureal A, Diab A, Wang L, Nurieva R. Distinct molecular and immune hallmarks of inflammatory arthritis induced by immune checkpoint inhibitors for cancer therapy. Nat Commun 13:1970, 2022. e-Pub 2022. PMID: 35413951.
40. Augustin RC, Leone RD, Naing A, Fong L, Bao R, Luke JJ. Next steps for clinical translation of adenosine pathway inhibition in cancer immunotherapy. J Immunother Cancer 10(2):e004089, 2022. e-Pub 2022. PMID: 35135866.
41. Santomasso BD, Nastoupil LJ, Adkins S, Lacchetti C, Schneider BJ, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Funchain P, Jaiyesimi I, Mammen JS, Naidoo J, Naing A, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Bollin K, Ghosh M. Management of Immune-Related Adverse Events in Patients Treated With Chimeric Antigen Receptor T-Cell Therapy: ASCO Guideline. J Clin Oncol 39(35):3978-3992, 2021. e-Pub 2021. PMID: 34724386.
42. Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, Atkins MB, Brassil KJ, Caterino JM, Chau I, Davies MJ, Ernstoff MS, Fecher L, Ghosh M, Jaiyesimi I, Mammen JS, Naing A, Nastoupil LJ, Phillips T, Porter LD, Reichner CA, Seigel C, Song JM, Spira A, Suarez-Almazor M, Swami U, Thompson JA, Vikas P, Wang Y, Weber JS, Funchain P, Bollin K. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update. J Clin Oncol 1:JCO2101440, 2021. e-Pub 2021. PMID: 34724392.
43. Pant S, Moyers JT, Naing A. Letter to the editor from Pant et al. J Immunother Cancer 9(11):e003991, 2021. e-Pub 2021. PMID: 34725215.
44. Dumbrava EE, Call SG, Huang HJ, Stuckett AL, Madwani K, Adat A, Hong DS, Piha-Paul SA, Subbiah V, Karp DD, Fu S, Naing A, Tsimberidou AM, Moulder SL, Koenig KH, Barcenas CH, Kee BK, Fogelman DR, Kopetz ES, Meric-Bernstam F, Janku F. PIK3CA mutations in plasma circulating tumor DNA predict survival and treatment outcomes in patients with advanced cancers. ESMO Open 6(5):100230, 2021. e-Pub 2021. PMID: 34479035.
45. Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs. e-Pub 2021. PMID: 34705134.
46. Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study. Invest New Drugs. e-Pub 2021. PMID: 34562230.
47. Ferrarotto R, Sousa LG, Qing Y, Kaya D, Stephen B, Jain D, Bell D, Pant S, Tsimberidou AM, Janku F, Blumenschein G, Glisson BS, Ahnert JR, Piha-Paul SA, Lee JJ, Wong MK, Lu C, Meric-Bernstam F, Naing A. Pembrolizumab in Patients with Refractory Cutaneous Squamous Cell Carcinoma: A Phase II Trial. Adv Ther 38(8):4581-4591, 2021. e-Pub 2021. PMID: 34241781.
48. Colen RR, Rolfo C, Ak M, Ayoub M, Ahmed S, Elshafeey N, Mamindla P, Zinn PO, Ng C, Vikram R, Bakas S, Peterson CB, Rodon Ahnert J, Subbiah V, Karp DD, Stephen B, Hajjar J, Naing A. Radiomics analysis for predicting pembrolizumab response in patients with advanced rare cancers. J Immunother Cancer, 2021. e-Pub 2021. PMID: 33849924.
49. Curigliano G, Gelderblom H, Mach N, Doi T, Tai WM, Forde PM, Sarantopoulos J, Bedard PL, Lin CC, Hodi FS, Wilgenhof S, Santoro A, Sabatos-Peyton C, Longmire TA, Xyrafas A, Sun H, Gutzwiller S, Manenti L, Naing A. Phase I/Ib clinical trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination With Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors. Clin Cancer Res, 2021. e-Pub 2021. PMID: 33883177.
50. Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs, 2021. e-Pub 2021. PMID: 33909232.
51. Hahn AW, Chahoud J, Campbell MT, Karp DD, Wang J, Stephen B, Tu SM, Pettaway CA, Naing A. Pembrolizumab for advanced penile cancer: a case series from a phase II basket trial. Invest New Drugs. e-Pub 2021. PMID: 33770291.
52. Tannir NM, Papadopoulos KP, Wong DJ, Aljumaily R, Hung A, Afable M, Kim JS, Ferry D, Drakaki A, Bendell J, Naing A. Pegilodecakin as monotherapy or in combination with anti-PD-1 or tyrosine kinase inhibitor in heavily pretreated patients with advanced renal cell carcinoma: Final results of cohorts A, G, H and I of IVY Phase I study. Int J Cancer. e-Pub 2021. PMID: 33709428.
53. Hajjar J, Mendoza T, Zhang L, Fu S, Piha-Paul SA, Hong DS, Janku F, Karp DD, Ballhausen A, Gong J, Zarifa A, Peterson CB, Meric-Bernstam F, Jenq R, Naing A. Associations between the gut microbiome and fatigue in cancer patients. Sci Rep 11(1):5847, 2021. e-Pub 2021. PMID: 33712647.
54. Alhalabi O, Hahn AW, Msaouel P, Andreev-Drakhlin AY, Meric-Bernstam F, Naing A, Piha-Paul S, Filip J, Pant S, Yap TA, Hong DS, Fu S, Karp D, Campbell E, Le H, Campbell MT, Shah AY, Tannir NM, Siefker-Radtke AO, Gao J, Roszik J, Subbiah V. Molecular profiling of metastatic bladder cancer early-phase clinical trial participants predicts patient outcomes. Mol Cancer Res 19(3):395-402, 2021. e-Pub 2021. PMID: 33323389.
55. Cascone T, Sacks RL, Subbiah IM, Drobnitzky N, Piha-Paul SA, Hong DS, Hess KR, Amini B, Bhatt T, Fu S, Naing A, Janku F, Karp D, Falchook GS, Conley AP, Sherman SI, Meric-Bernstam F, Ryan AJ, Heymach JV, Subbiah V. Safety and activity of vandetanib in combination with everolimus in patients with advanced solid tumors: a phase I study. ESMO Open 6(2):100079. e-Pub 2021. PMID: 33721621.
56. Huey RW, George GC, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul S, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Rodon J, Meric-Bernstam F, Shih YT, Hong DS. Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials. Oncologist. e-Pub 2021. PMID: 33783054.
57. Yao S, Janku F, Subbiah V, Stewart J, Patel SP, Kaseb A, Westin SN, Naing A, Tsimberidou AM, Hong D, Piha-Paul SA, Shi N, Johnston A, Bomalaski J, Fu S. Phase 1 trial of ADI-PEG20 plus cisplatin in patients with pretreated metastatic melanoma or other advanced solid malignancies. Br J Cancer. e-Pub 2021. PMID: 33674736.
58. Al-Zubidi N, Gombos DS, Hong DS, Subbiah V, Fu S, Ahnert JR, Piha-Paul SA, Tsimberidou AM, Karp DD, Bernstam FM, Naing A. Overview of Ocular Side Effects of Selinexor. Oncologist. e-Pub 2021. PMID: 33728727.
59. How JA, Jazaeri AA, Soliman PT, Fleming ND, Gong J, Piha-Paul SA, Janku F, Stephen B, Naing A. Pembrolizumab in vaginal and vulvar squamous cell carcinoma: a case series from a phase II basket trial. Sci Rep 11(1):3667, 2021. e-Pub 2021. PMID: 33574401.
60. Janku F, Sakamuri D, Kato S, Huang HJ, Call SG, Naing A, Holley VR, Patel SP, Amaria RN, Falchook GS, Piha-Paul SA, Zinner RG, Tsimberidou AM, Hong DS, Meric-Bernstam F. Dose-escalation study of vemurafenib with sorafenib or crizotinib in patients with BRAF-mutated advanced cancers. Cancer 127(3):391-402, 2021. e-Pub 2021. PMID: 33119140.
61. Alshawa A, Cadena AP, Stephen B, Reddy A, Mendoza TR, McQuinn L, Lawhorn K, Zarifa A, Bernhardt AM, Fessaheye S, Warneke CL, Chang JY, Naing A. Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial. Invest New Drugs. e-Pub 2021. PMID: 33580845.
62. Muñoz NM, Williams M, Dixon K, Dupuis C, McWatters A, Avritscher R, Manrique SZ, McHugh K, Murthy R, Tam A, Naing A, Patel SP, Leach D, Hartgerink JD, Young S, Prakash P, Hwu P, Sheth RA. Influence of injection technique, drug formulation and tumor microenvironment on intratumoral immunotherapy delivery and efficacy. J Immunother Cancer 9(2), 2021. e-Pub 2021. PMID: 33589526.
63. Hecht JR, Papadopoulos KP, Falchook GS, Patel MR, Infante JR, Aljumaily R, Wong DJ, Autio KA, Wainberg ZA, Bauer TM, Javle M, Pant S, Bendell J, Hung A, Ratti N, VanVlasselaer P, Verma R, Leveque J, Rao S, Oft M, Naing A. Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC). Invest New Drugs 39(1):182-192, 2021. e-Pub 2021. PMID: 32910338.
64. Tsimberidou AM, Vo HH, Subbiah V, Janku F, Piha-Paul S, Yilmaz B, Gong J, Faraz Naqvi M, Tu SM, Campbell M, Meric-Bernstam F, Naing A. Pembrolizumab in Patients with Advanced Metastatic Germ Cell Tumors. Oncologist. e-Pub 2021. PMID: 33491277.
65. How JA, Jazaeri A, Westin SN, Sood AK, Ramondetta LM, Xu M, Abonofal A, Karp DD, Subbiah V, Stephen B, Rodon JA, Yang F, Naing A. The clinical efficacy and safety of single-agent pembrolizumab in patients with recurrent granulosa cell tumors of the ovary: a case series from a phase II basket trial. Invest New Drugs. e-Pub 2021. PMID: 33415580.
66. Kim ST, Sheshadri A, Shannon V, Kontoyiannis DP, Kantarjian H, Garcia-Manero G, Ravandi F, Im JS, Boddu P, Bashoura L, Balachandran DD, Evans SE, Faiz S, Ruiz Vazquez W, Divenko M, Mathur R, Tippen SP, Gumbs C, Neelapu SS, Naing A, Wang L, Diab A, Futreal A, Nurieva R, Daver N. Distinct Immunophenotypes of T Cells in Bronchoalveolar Lavage Fluid From Leukemia Patients With Immune Checkpoint Inhibitors-Related Pulmonary Complications. Front Immunol, 2021. e-Pub 2021. PMID: 33552049.
67. Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Fu S, Subbiah V, Hong DS, Yap TA, Shah J, Milton DR, McQuinn L, Gong J, Tran Y, Carter BW, Colen R, Meric-Bernstam F, Naing A. Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors. Exp Hematol Oncol 10:59, 2021. e-Pub 2021. PMID: 3465890.
68. Balmanoukian AS, Infante JR, Aljumaily R, Naing A, Chintakuntlawar AV, Rizvi NA, Ross HJ, Gordon M, Mallinder PR, Elgeioushi N, González-García I, Standifer N, Cann J, Durham N, Rahimian S, Kumar R, Denlinger CS. Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors. Clin Cancer Res 26(23):6196-6203, 2020. e-Pub 2020. PMID: 32887725.
69. Majd N, Waguespack SG, Janku F, Fu S, Penas-Prado M, Xu M, Alshawa A, Kamiya-Matsuoka C, Raza SM, McCutcheon IE, Naing A. Efficacy of pembrolizumab in patients with pituitary carcinoma: report of four cases from a phase II study. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33427689.
70. Naing A, Hajjar J, Gulley JL, Atkins MB, Ciliberto G, Meric-Bernstam F, Hwu P. Strategies for improving the management of immune-related adverse events. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33310772.
71. Cesano A, Cannarile MA, Gnjatic S, Gomes B, Guinney J, Karanikas V, Karkada M, Kirkwood JM, Kotlan B, Masucci GV, Meeusen E, Monette A, Naing A, Thorsson V, Tschernia N, Wang E, Wells DK, Wyant TL, Rutella S. Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II-practical challenges. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33323463.
72. Janku F, Park H, Call SG, Madwani K, Oki Y, Subbiah V, Hong DS, Naing A, Velez-Bravo VM, Barnes TG, Hagemeister FB, Falchook GS, Karp DD, Wheler JJ, Piha-Paul SA, Garrido-Laguna I, Shpall EJ, Fayad LE, Neelapu SS, Meric-Bernstam F, Kurzrock R, Fanale MA. Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma. Clin Cancer Res 26(21):5579-5587, 2020. e-Pub 2020. PMID: 33055173.
73. Rischin D, Gil-Martin M, González-Martin A, Braña I, Hou JY, Cho D, Falchook GS, Formenti S, Jabbour S, Moore K, Naing A, Papadopoulos KP, Baranda J, Fury W, Feng M, Stankevich E, Li J, Yama-Dang NA, Yoo SY, Lowy I, Mathias M, Fury MG. PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. Gynecol Oncol 159(2):322-328, 2020. e-Pub 2020. PMID: 32917410.
74. Hahn AW, Alhalabi O, Msaouel P, Meric-Bernstam F, Naing A, Jonasch E, Piha-Paul S, Hong D, Pant S, Yap T, Campbell E, Le H, Tannir NM, Roszik J, Subbiah V. Validation of prognostic scoring systems for patients with metastatic renal cell carcinoma enrolled in phase I clinical trials. ESMO Open 5(6), 2020. e-Pub 2020.
75. Smith DC, Kroiss M, Kebebew E, Habra MA, Chugh R, Schneider BJ, Fassnacht M, Jafarinasabian P, Ijzerman MM, Lin VH, Mohideen P, Naing A. A phase 1 study of nevanimibe HCl, a novel adrenal-specific sterol O-acyltransferase 1 (SOAT1) inhibitor, in adrenocortical carcinoma. Invest New Drugs 38(5):1421-1429, 2020. e-Pub 2020. PMID: 31984451.
76. Rutella S, Cannarile MA, Gnjatic S, Gomes B, Guinney J, Karanikas V, Karkada M, Kirkwood JM, Kotlan B, Masucci GV, Meeusen E, Monette A, Naing A, Thorsson V, Tschernia N, Wang E, Wells DK, Wyant TL, Cesano A. Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33127656.
77. Ott PA, Hu-Lieskovan S, Chmielowski B, Govindan R, Naing A, Bhardwaj N, Margolin K, Awad MM, Hellmann MD, Lin JJ, Friedlander T, Bushway ME, Balogh KN, Sciuto TE, Kohler V, Turnbull SJ, Besada R, Curran RR, Trapp B, Scherer J, Poran A, Harjanto D, Barthelme D, Ting YS, Dong JZ, Ware Y, Huang Y, Huang Z, Wanamaker A, Cleary LD, Moles MA, Manson K, Greshock J, Khondker ZS, Fritsch E, Rooney MS, DeMario M, Gaynor RB, Srinivasan L. A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer. Cell 183(2):347-362.e24, 2020. e-Pub 2020. PMID: 33064988.
78. Mendoza T, Sheshadri A, Altan M, Hess K, George G, Stephen B, Castillo L, Rodriguez E, Gong J, Peterson C, Rodon Ahnert J, Fu S, Piha-Paul SA, Pant S, Dumbrava E, Yap TA, Janku F, Tsimberidou AM, Subbiah V, Karp DD, Zarifa A, McQuinn LM, Cleeland C, Hong DS, Naing A. Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 33097611.
79. Frumovitz M, Westin SN, Salvo G, Zarifa A, Xu M, Yap TA, Rodon AJ, Karp DD, Abonofal A, Jazaeri AA, Naing A. Phase II study of pembrolizumab efficacy and safety in women with recurrent small cell neuroendocrine carcinoma of the lower genital tract. Gynecol Oncol 158(3):570-575, 2020. e-Pub 2020. PMID: 32534809.
80. Naing A, Eder JP, Piha-Paul SA, Gimmi C, Hussey E, Zhang S, Hildebrand V, Hosagrahara V, Habermehl C, Moisan J, Papadopoulos KP. Preclinical investigations and a first-in-human phase I trial of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase 1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid tumors. J Immunother Cancer 8(2), 2020. e-Pub 2020. PMID: 32843490.
81. Jimenez C, Subbiah V, Stephen B, Ma J, Milton D, Xu M, Zarifa A, Akhmedzhanov FO, Tsimberidou A, Habra MA, Rodon Anhert J, Fu S, Naing A. Phase II Clinical Trial of Pembrolizumab in Patients with Progressive Metastatic Pheochromocytomas and Paragangliomas. Cancers (Basel) 12(8), 2020. e-Pub 2020. PMID: 32824391.
82. George GC, Mendoza TR, Iwuanyanwu EC, Manandhar M, Afshar SF, Piha-Paul SA, Tsimberidou A, Naing A, Cleeland CS, Hong DS. Factors affecting symptom presentation in an early-phase clinical trials clinic patient population. Invest New Drugs 38(4):1166-1174, 2020. e-Pub 2020. PMID: 31761957.
83. Amin HM, Morani AC, Daw NC, Lamhamedi-Cherradi SE, Subbiah V, Menegaz BA, Vishwamitra D, Eskandari G, George B, Benjamin RS, Patel S, Song J, Lazar AJ, Wang WL, Kurzrock R, Pappo A, Anderson PM, Schwartz GK, Araujo D, Cuglievan B, Ratan R, McCall D, Mohiuddin S, Livingston JA, Molina ER, Naing A, Ludwig JA. IGF-1R/mTOR Targeted Therapy for Ewing Sarcoma: A Meta-Analysis of Five IGF-1R-Related Trials Matched to Proteomic and Radiologic Predictive Biomarkers. Cancers (Basel) 12(7), 2020. e-Pub 2020. PMID: 32630797.
84. Hong DS, Parikh A, Shapiro GI, Varga A, Naing A, Meric-Bernstam F, Ö A, Reyderman L, Binder TA, Ren M, Liu M, Dayal S, Siu AY, Sachdev P, Xu L, Bhagawati-Prasad V, Tchakov I, Ooi CE, Bao X, Marabelle A. First-in-human phase I study of immunomodulatory E7046, an antagonist of PGE2-receptor E-type 4 (EP4), in patients with advanced cancers. J Immunother Cancer 8(1), 2020. e-Pub 2020. PMID: 32554609.
85. Groisberg R, Roszik J, Conley AP, Lazar AJ, Portal DE, Hong DS, Naing A, Herzog CE, Somaiah N, Zarzour MA, Patel S, Brown RE, Subbiah V. Genomics, Morphoproteomics, and Treatment Patterns of Patients with Alveolar Soft Part Sarcoma and Response to Multiple Experimental Therapies. Mol Cancer Ther 19(5):1165-1172, 2020. e-Pub 2020. PMID: 32127467.
86. Tapia C, Aung PP, Roy-Chowdhuri S, Xu M, Ouyang F, Alshawa A, Hajjar J, Singh G, Yang V, Castillo L, Le H, Murthy R, Stephen B, Hess KR, Wistuba I, Naing A. Decrease in tumor content assessed in biopsies is associated with improved treatment outcome response to pembrolizumab in patients with rare tumors. J Immunother Cancer 8(1), 2020. e-Pub 2020. PMID: 32303619.
87. Autio KA, Boni V, Humphrey RW, Naing A. Probody therapeutics: An emerging class of therapies designed to enhance on-target effects with reduced off-tumor toxicity for use in immuno-oncology. Clin Cancer Res 26(5):984-989, 2020. e-Pub 2020. PMID: 31601568.
88. Naing A, Meric-Bernstam F, Stephen B, Karp DD, Hajjar J, Rodon Ahnert J, Piha-Paul SA, Colen RR, Jimenez C, Raghav KP, Ferrarotto R, Tu SM, Campbell M, Wang L, Sabir SH, Tapia C, Bernatchez C, Frumovitz M, Tannir N, Ravi V, Khan S, Painter JM, Abonofal A, Gong J, Alshawa A, McQuinn LM, Xu M, Ahmed S, Subbiah V, Hong DS, Pant S, Yap TA, Tsimberidou AM, Dumbrava EEI, Janku F, Fu S, Simon RM, Hess KR, Varadhachary GR, Habra MA. Phase 2 study of pembrolizumab in patients with advanced rare cancers. J Immunother Cancer 8(1), 2020. e-Pub 2020. PMID: 32188704.
89. Naing A, Gainor JF, Gelderblom H, Forde PM, Butler MO, Lin CC, Sharma S, Ochoa de Olza M, Varga A, Taylor M, Schellens JHM, Wu H, Sun H, Silva AP, Faris J, Mataraza J, Cameron S, Bauer TM. A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. J Immunother Cancer 8(1), 2020. e-Pub 2020. PMID: 32179633.
90. Papadopoulos KP, Johnson ML, Lockhart AC, Moore K, Falchook GS, Formenti SC, Naing A, Carvajal RD, Rosen LS, Weiss GJ, Leidner RS, Li J, Paccaly A, Feng M, Stankevich E, Lowy I, Fury MG, Crittenden MR. First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies. Clin Cancer Res 26(5):1025-1033, 2020. e-Pub 2020. PMID: 31796520.
91. Wang Y, Janku F, Piha-Paul S, Hess K, Broaddus R, Liu L, Shi N, Overman M, Kopetz S, Subbiah V, Naing A, Hong D, Tsimberidou AM, Karp D, Yao J, Fu S. Phase I studies of vorinostat with ixazomib or pazopanib imply a role of antiangiogenesis-based therapy for TP53 mutant malignancies. Sci Rep 10(1):3080, 2020. e-Pub 2020. PMID: 32080210.
92. Miller ED, Abu-Sbeih H, Styskel B, Nogueras Gonzalez GM, Blechacz B, Naing A, Chalasani N. Clinical Characteristics and Adverse Impact of Hepatotoxicity due to Immune Checkpoint Inhibitors. Am J Gastroenterol 115(2):251-261, 2020. e-Pub 2020. PMID: 31789632.
93. Subbiah V, Dumbrava EI, Jiang Y, Thein KZ, Naing A, Hong DS, Fu S, Piha-Paul SA, Tsimberidou AM, Janku F, Meric-Bernstam F, Kurzrock R, Falchook G. Dual EGFR blockade with cetuximab and erlotinib combined with anti-VEGF antibody bevacizumab in advanced solid tumors: a phase 1 dose escalation triplet combination trial. Exp Hematol Oncol 9:7, 2020. e-Pub 2020. PMID: 32337094.
94. Creasy CA, Forget MA, Singh G, Tapia C, Xu M, Stephen B, Sabir S, Meric-Bernstam F, Haymaker C, Bernatchez C, Naing A. Exposure to anti-PD-1 causes functional differences in tumor-infiltrating lymphocytes in rare solid tumors. Eur J Immunol 49(12):2245-2251, 2019. e-Pub 2019. PMID: 31532833.
95. Welsh JW, Tang C, de Groot P, Naing A, Hess KR, Heymach JV, Papadimitrakopoulou VA, Cushman TR, Subbiah V, Chang JY, Simon GR, Ramapriyan R, Barsoumian HB, Menon H, Cortez MA, Massarelli E, Nguyen Q, Sharma P, Allison JP, Diab A, Verma V, Raju U, Shaaban SG, Dadu R, Cabanillas ME, Wang K, Anderson C, Gomez DR, Hahn S, Komaki R, Hong DS. Phase II Trial of Ipilimumab with Stereotactic Radiation Therapy for Metastatic Disease: Outcomes, Toxicities, and Low-Dose Radiation-Related Abscopal Responses. Cancer Immunol Res 7(12):1903-1909, 2019. e-Pub 2019. PMID: 31658994.
96. Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Janku F, Naing A, Fu S, Piha-Paul S, Cartwright C, Broaddus RR, Nogueras Gonzalez GM, Hwu P, Kurzrock R. Long-term overall survival and prognostic score predicting survival: the IMPACT study in precision medicine. J Hematol Oncol 12(1):145, 2019. e-Pub 2019. PMID: 31888672.
97. Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with Pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicenter, multicohort, open-label, phase 1b trial. Lancet Oncol 20(11):1544-1555, 2019. e-Pub 2019.
98. Looney TJ, Duose DY, Lowman G, Linch E, Hajjar J, Topacio-Hall D, Xu M, Zheng J, Alshawa A, Tapia C, Stephen B, Wang L, Meric-Bernstam F, Miller L, Glavin A, Lin L, Gong J, Conroy J, Morrison C, Hyland F, Naing A. Haplotype analysis of the T-cell receptor beta (TCRB) locus by long-amplicon TCRB repertoire sequencing. J Immunother Precis Oncol 2 4:137-143, 2019. e-Pub 2019.
99. Maymani H, Hess K, Groisberg R, Hong DS, Naing A, Piha-Paul SA, Janku F, Fu S, Tsimberidou AM, Pant S, Karp D, Liu S, Sun M, Heymach J, Simon G, Meric-Bernstam F, Subbiah V. Corrigendum to “Predicting outcomes in patients with advanced non-small cell lung cancer emrolled in early phase immunotherapy trials”. Lung Cancer 120:137-141, 2019. e-Pub 2019.
100. Habra MA, Stephen B, Campbell M, Hess K, Tapia C, Xu M, Rodon Ahnert J, Jimenez C, Lee JE, Perrier ND, Boraddus RR, Pant S, Subbiah V, Hong DS, Zarifa A, Fu S, Karp DD, Meric-Bernstam F, Naing A. Phase II clinical trial of Pembrolizumab efficacy and safety in advanced adrenocortical carcinoma. J Immunother Cancer 7(1):253, 2019. e-Pub 2019.
101. Naing A, Infante J, Goel S, Burris H, Black C, Marshall S, Achour I, Barbee S, May R, Morehouse C, Pollizzi K, Song X, Steele K, Elgeioushi N, Walcott, Karakunnel J, LoRusso P, Weise A, Eder J, Curti B, Oberst M. Anti-PD-1 monoclonal antibody MEDI0680 in a phase I study of patients with advanced solid malignancies. J Immunother Cancer 7(1):225, 2019. e-Pub 2019.
102. Abu-Sbeih H, Tran CN, Ge PS, Bhutani MS, Alasadi M, Naing A, Jazaeri AA, Wang Y. Case series of cancer patients who developed cholecystitis related to immune checkpoint inhibitor treatment. J Immunother Cancer 7(1):118, 2019. e-Pub 2019.
103. Lopez G, Salas CA, Cadiz F, Barriga C, Gonzalez P, Acevedo S, Raimilla P, Pincheira P, Naing A, Quiroga M. Complementary and integrative medicine use in individuals seeking convential medicine oncology care in Chile: Prevalence and patient characteristics. J Glob Oncol 5:1-6, 2019. e-Pub 2019.
104. Palaskas N, Morgan J, Daigle T, Banchs J, Durand JB, Hong D, Naing A, Le H, Hassan SA, Karimzad K, Mouhayer E, Kim P, Lopez-Mattei J, Thompson K, Yusuf SW, Iliescu C. Targeted cancer therapies with pericardial effusions requiring pericardiocentesis focusing on immune checkpoint inhibitors. Am J Cardiol 123(8):1351-1357, 2019. e-Pub 2019.
105. Torres HA, Economides MP, Angelidakis G, Hosry J, Kyvernitakis A, Mahale P, Jiang Y, Miller E, Blechacz B, Naing A, Samaniego F, Kaseb A, Raad II, Granwehr BP. Sofosbuvir-Based Therapy in Hepatitis C Virus-infeced Cancer Patients: A Prospective Observational Study. Am J Gastroenterol, 2018. e-Pub 2018. PMID: 30410039.
106. Fountzilas E, Krishnan E, Janku F, Fu S, Karp DD, Naing A, Subbiah V, Hong DS, Piha-Paul SA, Vining DJ, Tsimberidou AM. A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without intravenous bevacizumab, in patient with advanced cancer and predominant liver involvement. Cancer Chermother Pharmacol 82(5):877-885, 2018. e-Pub 2018. PMID: 30182147.
107. Fujii T, Naing A, Rolfo C, Hajjar J. Biomarkers of response to immune checkpoint blockade in cancer treatment. Crit Rev Oncol Hematol(130):108-120, 2018. e-Pub 2018. PMID: 30196907.
108. Dembla V, Somaiah N, Parata P, Hess K, Fu S, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Shaw K, Meric-Bernstam F, Hong DS. Prevalence of MDM2 amplification and coalterations in 523 advanced cancer patients in the MD Anderson phase 1 clinic. Oncotarget 9(69):33232-33243, 2018. e-Pub 2018. PMID: 30237864.
109. Yalcin S, Hurmuz P, McQuinn L, Naing A. Prevalence of Complementary Medicine Use in Patients with Cancer: A Turkish Comprehensive Cancer Center Experience. J Glob Oncol 4:1-6, 2018. e-Pub 2018. PMID: 30241173.
110. Wang Y, Wang Z, Piha-Paul S, Janku F, Subbiah V, Shi N, Hess K, Broaddus R, Shan B, Naing A, Hong D, Tsimberidou AM, Karp D, Lu C, Papadimitrakopoulou V, Heymach J, Meric-Bernstam F, Fu S. Outcome analysis of Phase I trial patients with metastatic KRAS and/or TP53 mutant non-small cell lung cancer. Oncotarget, 2018. e-Pub 2018. PMID: 30279957.
111. Colen RR, Fujii T, Bilen MA, Kotrotsou A, Abrol S, Hess KR, Hajjar J, Suarez-Almazor ME, Alshawa A, Hong DS, Giniebra-Camejo D, Stephen B, Subbiah V, Sheshadri A, Mendoza T, Fu S, Sharma P, Meric-Bernstam F, Naing A. Radiomics to predict immunotherapy-induced pneumonitis: proof of concept. Invest New Drugs 36(4):601-607, 2018. e-Pub 2018. PMID: 29075985.
112. Subbiah V, Murthy R, Hong DS, Prins RM, Hosin C, Hendricks K, Kolli D, Noffsinger L, Brown R, McGuire M, Fu S, Piha-Paul S, Naing A, Conley AP, Benjamin RS, Kaur I, Bosch ML. Cytokines Produced by Dendritic Cells Administered Intratumorally Correlate with Clinical Outcome in Patients with Diverse Cancers. Clin Cancer Res 24(16):3845-3856, 2018. e-Pub 2018.
113. Fujii T, Colen RR, Bilen MA, Hess KR, Hajjar J, Suarez-Almazor ME, Alshawa A, Hong DS, Tsimberidou A, Janku F, Gong J, Stephen B, Subbiah V, Piha-Paul SA, Fu S, Sharma P, Mendoza T, Patel A, Thirumurthi S, Sheshadri A, Meric-Bernstam F, Naing A. Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience. Invest New Drugs 36(4):638-646, 2018. e-Pub 2018. PMID: 29159766.
114. Parseghian CM, Patnana M, Bhosale P, Hess K, Shih YT, Kim B, Kopetz S, Overman MJ, Varadhachary GR, Javle M, Naing A, Piha-Paul S, Hong D, Le H, Subbiah V, Pant S. Evaluating for Psuedoprogression in Colorectal and Pancreatic Tumors Treated with Immunotherapy. J Immunother 41(6):284-291, 2018. e-Pub 2018. PMID: 29668571.
115. Maymani H, Hess K, Groisber R, Hong DS, Naing A, Piha-Paul S, Janku F, Fu S, Tsimberidou AM, Pant S, Karp D, Liu S, Sun M, Heymach J, Simon G, Meric-Bernstam F, Subbiah V. Predicting outcomes in patients with advanced non-small cell lung cancer enrolled in early phase immunotherapy trials. Lung Cancer 120:137-141, 2018. e-Pub 2018. PMID: 29748008.
116. Liu L, Toung JM, Jassowicz AF, Vijayaraghavan R, Kang H, Zhang R, Kruglyak KM, Huang HJ, Hinoue T, Shen H, Salathia NS, Hong DS, Naing A, Subbiah V, Piha-Paul SA, Bibikova M, Granger G, Barnes B, Shen R, Gutekunst K, Fu S, Tsimberidou AM, Lu C, Eng C, Moulder SL, Kopetz ES, Amaria RN, Meric-Bernstam F, Laird PW, Fan JB, Janku F. Targeted Methylation Sequencing of Plasma Cell-free DNA for Cancer Detection and Classification. Ann Oncol 29(6):1445-1453, 2018. e-Pub 2018. PMID: 29635542.
117. Brahmer JR, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, Chau I, Ernstoff MS, Gardner JM, Ginex P, Hallmeyer S, Holter Chakrabarty J, Leighl NB, Mammen JS, McDermott DF, Naing A, Nastoupil LJ, Phillips T, Porter LD, Puzanov I, Reichner CA, Santomasso BD, Seigel C, Spira A, Suarez-Almazor ME, Wang Y, Weber JS, Wolchok JD, Thompson JA, Cancer Network NC. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 36(17):JCO2017776385, 2018. e-Pub 2018. PMID: 29442540.
118. Ghosh P, Chandler AG, Hobbs BP, Sun J, Rong J, Hong D, Subbiah V, Janku F, Naing A, Hwu WJ, Ng CS. Quantification of the Effect of Shuttling on Computed Tomography Perfusion Parameters by Investigation of Aortic Inputs on Different Table Positions From Shuttle-Mode Scans of Lung and Liver Tumors. J Comput Assist Tomogr 42(3):357-364, 2018. e-Pub 2018. PMID: 29189398.
119. Sen S, Kato S, Agarwal R, Piha-Paul S, Hess K, Karp D, Janku F, Fu S, Naing A, Pant S, Falchook G, Tang C, Wu X, Ye Y, Tsimberidou A, Subbiah V, Kurzrock R, Byers L, Westin S, Lim J, Bean S, Bass A, Nguyen L, Meric-Bernstam F, Hong D. Phase I study of nab-paclitaxel, gemcitabine, and bevacizumab in patients with advanced cancers. Br J Cancer 118(11):1419-1424, 2018. e-Pub 2018. PMID: 29695765.
120. Sen S, Hess K, Hong DS, Naing A, Piha-Paul S, Janku F, Fu S, Subbiah IM, Liu H, Khanji R, Huang L, Moorthy S, Karp DD, Tsimberidou A, Meric-Bernstam F, Subbiah V. Development of a prognostic scoring system for patients with advanced cancer enrolled in immune checkpoint inhibitor phase 1 clinical trials. Br J Cancer 118(6):763-769, 2018. e-Pub 2018. PMID: 29462132.
121. Pucci M, Reclusa Asiáin P, Duréndez Sáez E, Jantus-Lewintre E, Malarani M, Khan S, Fontana S, Naing A, Passiglia F, Raez LE, Rolfo C, Taverna S. Extracellular Vesicles As miRNA Nano-Shuttles: Dual Role in Tumor Progression. Springer Link, 2018. e-Pub 2018. PMID: 29374391.
122. Naing A, Infante JR, Papadopoulos KP, Chan IH, Shen C, Np R, Rojo B, Autio KA, Wong DJ, Patel MR, Ott PA, Palchook GS, Pant S, Hung A, Pekarek KL, Wu V, Adamow M, McCauley S, Mumm JB, Wong P, Van Vlasselaer P, Levegue J, Tannir NM, Oft M. PEGylated IL-10 (Pegildecakin) Induces Systemic Immune Activation, CD8+ T Cell Invigoration and Polyclonal T Cell Expansion in Cancer Patients. Cancer Cell 34(5):775-791, 2018. e-Pub 2018. PMID: 30423397.
123. Hinchcliff E, Hong D, Le H, Chisholm G, Iyer R, Naing A, Hwu P, Jazaeri A. Characteristics and outcomes of patients with recurrent ovarian cancer undergoing early phase immune checkpoint inhibitor clinical trials. Gynecol Oncol 151(3):407-413, 2018. e-Pub 2018. PMID: 30366646.
124. Möhrmann L, Huang HJ, Hong DS, Tsimberidou AM, Fu S, Piha-Paul SA, Subbiah V, Karp DD, Naing A, Krug A, Enderle D, Priewasser T, Noerholm M, Eitan E, Coticchia C, Stoll G, Jordan LM, Eng C, Kopetz ES, Skog J, Meric-Bernstam F, Janku F. Liquid Biopsies Using Plasma Exosomal Nucleic Acids and Plasma Cell-Free DNA Compared with Clinical Outcomes of Patients with Advanced Cancers. Clinical Cancer Research, 2018. e-Pub 2018. PMID: 29051321.
125. Bhatty M, Kato S, Piha-Paul SA, Naing A, Subbiah V, Huang HJ, Karp DD, Tsimberidou AM, Zinner RG, Hwu WJ, Javle M, Patel SP, Hu MI, Varadhachary GR, Conley AP, Ramzanali NM, Holley VR, Kurzrock R, Meric-Bernstam F, Kwang Chae Y, Kim KB, Falchook GS, Janku F. Phase 1 study of the combination of vemurafenib, carboplatin, and paclitaxel in patients With BRAF-mutated melanoma and other advanced malignancies. Cancer, 2018. e-Pub 2018. PMID: 30383888.
126. Sakamuri D, Glitza IC, Betancourt Cuellar SL, Subbiah V, Fu S, Tsimberidou AM, Wheler JJ, Hong DS, Naing A, Falchook GS, Fanale MA, Cabanillas ME, Janku F. Phase 1 dose-escalation study of anti CTLA-4 antibody ipilimumab and lenalidomide in patients with advanced cancers. Mol Cancer Ther. e-Pub 2017. PMID: 29237802.
127. Groisberg R, Hong DS, Behrang A, Hess K, Janku F, Piha-Paul S, Naing A, Fu S, Benjamin R, Patel S, Somaiah N, Conley A, Meric-Bernstam F, Subbiah V. Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials. J Immunother Cancer 5(1):100, 2017. e-Pub 2017. PMID: 29254498.
128. Goldstein JB, Tang C, Hess KR, Hong D, Subbiah V, Janku F, Fu S, Karp DD, Naing A, Tsimberidou AM, Wheler J, Zinner R, Javle M, Varadhachary GR, Wolff RA, Fogelman DR, Meric-Bernstam F, Piha-Paul SA. Outcomes of phase I clinical trials for patients with advanced pancreatic cancer: update of the MD Anderson Cancer Center experience. Oncotarget 8(50):87163-87173, 2017. e-Pub 2017. PMID: 29152071.
129. Shimizu Y, Furuya H, Tamashiro PM, Iino K, Chan OTM, Goodison S, Pagano I, Hokutan K, Peres R, Loo LWM, Hernandez B, Naing A, Chong CDK, Rosser CJ, Kawamori T. Genetic deletion of Sphingosine Kinase 1 suppresses mouse breast tumor development in a HER2 transgenic model. Carcinogenesis. e-Pub 2017. PMID: 28968647.
130. Arango NP, Yuca E, Zhao M, Evans KW, Scott S, Kim C, Gonzalez-Angulo AM, Janku F, Ueno NT, Tripathy D, Akcakanat A, Naing A, Meric-Bernstam F. Selinexor (KPT-330) demonstrates anti-tumor efficacy in preclinical models of triple-negative breast cancer. Breast Cancer Res 19(1):93, 2017. e-Pub 2017. PMID: 28810913.
131. Kehl KL, Fullmer CP, Fu S, George GC, Hess KR, Janku F, Karp DD, Kato S, Kizer CK, Kurzrock R, Naing A, Pant S, Piha-Paul SA, Subbiah V, Tsimberidou AM, Hong DS. Insurance clearance for early-phase oncology clinical trials following the Affordable Care Act. Clin Cancer Res, 2017. e-Pub 2017.
132. Wang Z, Piha-Paul S, Janku F, Subbiah V, Shi N, Gong J, Wathoo C, Shaw K, Hess K, Broaddus R, Naing A, Hong D, Tsimberidou AM, Karp D, Yao J, Meric-Bernstam F, Fu S. Antiangiogenesis and gene aberration-related therapy may improve overall survival in patients with concurrent KRAS and TP53 hotspot mutant cancer. Oncotarget. e-Pub 2017. PMID: 28430579.
133. Subbiah V, Khawaja MR, Hong DS, Amini B, Yungfang J, Liu H, Johnson A, Schrock AB, Ali SM, Sun JX, Fabrizio D, Piha-Paul S, Fu S, Tsimberidou AM, Naing A, Janku F, Karp DD, Overman M, Eng C, Kopetz S, Meric-Bernstam F, Falchook GS. First-in-human trial of multikinase VEGF inhibitor regorafenib and anti-EGFR antibody cetuximab in advanced cancer patients. JCI Insight 2(8). e-Pub 2017. PMID: 28422758.
134. Mahadevan D, Mita M, Richards D, McClay E, Heist RS, Kumar A, Sundararajan S, Naing A. Phase I single dose, two-period and two-sequence cross-over trial to evaluate the relative bioavailability of two oral pimasertib formulations in advanced cancer patients. Cancer Chemother Parmacol 79(4):681-688, 2017. e-Pub 2017.
135. Tang C, Welsh JW, de Groot P, Massarelli E, Chang JY, Hess KR, Basu S, Curran MA, Cabanillas ME, Subbiah V, Fu S, Tsimberidou AM, Karp D, Gomez DR, Diab A, Komaki R, Heymach JV, Sharma P, Naing A, Hong DS. Ipilimumab with stereotactic ablative radiation therapy: Phase I results and immunologic correlates from peripheral T-cells. Clin Cancer Res 23(6):1388-1396, 2017. e-Pub 2017. PMID: 27649551.
136. Janku F, Huang HJ, Fujii T, Shelton DN, Madwani K, Fu S, Tsimberidou AM, Piha-Paul SA, Wheler JJ, Zinner RG, Naing A, Hong DS, Karp DD, Cabrilo G, Kopetz ES, Subbiah V, Luthra R, Kee BK, Eng C, Morris VK, Karlin-Neumann GA, Meric-Bernstam F. Multiplex KRASG12/G13 Mutation Testing of Unamplified Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using Droplet Digital Polymerase Chain Reaction. Ann Oncol 28(3):642-650, 2017. e-Pub 2017. PMID: 27993791.
137. Mita M, Fu S, Piha-Paul SA, Janku F, Mita A, Natale R, Guo W, Zhao C, Kurzrock R, Naing A. Phase I trial of MEK 1/2 inhibitor pimasertib combined with mTOR inhibitor temsirolimus in patients with advanced solid tumors. Invest New Drugs. e-Pub 2017. PMID: 28194539.
138. Bupathi M, Hajjar J, Bean S, Fu S, Hong D, Karp D, Stephen B, Hess K, Meric-Bernstam F, Naing A. Incidence of infusion reactions to anti-neoplastic agents in early phase clinical trials: The MD Anderson Cancer Center experience. Invest New Drugs 35(1):59-67, 2017. e-Pub 2017. PMID: 27687047.
139. Subbiah IM, Wheler JJ, Hess KR, Hong DS, Naing A, Fu S, Kurzrock R, Tsimberidou AM. Outcomes of patients 65 years old with advanced cancer treated on phase I trials at MD Anderson Cancer Center. Int J Cancer 140(1):208-215, 2017. e-Pub 2017. PMID: 27599876.
140. Kinahan H, Maiti A, Hess K, Dempsey J, Beatty L, Baldwin S, Hong DS, Naing A, Fu S, Tsimberidou AM, Piha-Paul S, Janku F, Karp D, Reddy S, Yennu S, Epner D, Bruera E, Meric-Bernstam F, Falchook G, Subbiah V. Post-Discharge Survival Outcomes of Patients with Advanced Cancer from the University of Texas MD Anderson Cancer Center Investigational Cancer Therapeutics (Phase I Trials) Inpatient Unit. Oncology 92(1):14-20, 2017. e-Pub 2017. PMID: 27802448.
141. Tsimberidou AM, Hong DS, Ye Y, Cartwright C, Wheler JJ, Falchook GS, Naing A, Fu S, Piha-Paul S, Janku F, Meric-Bernstam F, Hwu P, Kee B, Kies MS, Broaddus R, Mendelsohn J, Hess KR, Kurzrock R. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson Precision Medicine Study. JCO Precis Oncol 2017, 2017. e-Pub 2017. PMID: 29082359.
142. Reilley MJ, Bailey A, Subbiah V, Janku F, Naing A, Falchook G, Karp D, Piha-Paul S, Tsimberidou A, Fu S, Lim J, Bean S, Bass A, Montez S, Vence L, Sharma P, Allison J, Meric-Bernstam F, Hong DS. Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies. J Immunother Cancer 5:35, 2017. e-Pub 2017. PMID: 28428884.
143. Lamhamedi-Cherradi SE, Menegaz BA, Ramamoorthy V, Vishwamitra D, Wang Y, Maywald RL, Buford AS, Fokt I, Skora S, Wang J, Naing A, Lazar AJ, Rohren EM, Daw NC, Subbiah V, Benjamin RS, Ratan R, Priebe W, Mikos AG, Amin HM, Ludwig JA. IGF-1R and mTOR Blockade: Novel Resistance Mechanisms and Synergistic Drug Combinations for Ewing Sarcoma. J Natl Cancer Inst 108(12), 2016. e-Pub 2016. PMID: 27576731.
144. Bilen MA, Hess KR, Campbell MT, Wang J, Broaddus RR, Karam JA, Ward JF, Wood CG, Choi SL, Rao P, Zhang M, Naing A, General R, Cauley DH, Lin SH, Logothetis CJ, Pisters LL, Tu SM. Intratumoral heterogeneity and chemoresistance in nonseminomatous germ cell tumor of the testis. Oncotarget. e-Pub 2016. PMID: 27861143.
145. Wang Z, Shi N, Naing A, Janku F, Subbiah V, Araujo DM, Patel SR, Ludwig JA, Ramondetta LM, Levenback CF, Ramirez PT, Piha-Paul SA, Hong D, Karp DD, Tsimberidou AM, Meric-Bernstam F, Fu S. Survival of patients with metastatic leiomyosarcoma: the MD Anderson Clinical Center for targeted therapy experience. Cancer Med. e-Pub 2016. PMID: 27882721.
146. Economides MP, Mahale P, Kyvernitakis A, Turturo F, Kantarjian H, Naing A, Hosry J, Shigle TL, Kaseb A, Torres HA. Concomitant use of direct-acting antivirals and chemotherapy in hepatitis C virus-infected patients with cancer. Aliment Pharmacol Ther. e-Pub 2016. PMID: 27730654.
147. Subbiah V, Hess KR, Khawaja MR, Wagner MJ, Tang C, Naing A, Fu S, Janku F, Piha-Paul S, Tsimberidou AM, Herzog CE, Ludwig JA, Patel S, Ravi V, Benjamin RS, Meric-Bernstam F, Hong DS. Evaluation of Novel Targeted Therapies in Aggressive Biology Sarcoma Patients after progression from US FDA approved Therapies. Sci Rep 6:35448, 2016. e-Pub 2016. PMID: 27748430.
148. Park H, Garrido-Laguna I, Naing A, Fu S, Falchook GS, Piha-Paul SA, Wheler JJ, Hong DS, Tsimberidou AM, Subbiah V, Zinner RG, Kaseb AO, Patel S, Fanale MA, Velez-Bravo VM, Meric-Bernstam F, Kurzrock R, Janku F. Phase I dose-escalation study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancy. Oncotarget. e-Pub 2016. PMID: 27589687.
149. Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. e-Pub 2016. PMID: 27528724.
150. George GC, Iwuanyanwu EC, Anderson KO, Yusuf A, Zinner RG, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Janku F, Subbiah V, Cleeland CS, Mendoza TR, Hong DS. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials. Cancer. e-Pub 2016. PMID: 27412379.
151. Livingston JA, Hess KR, Naing A, Hong DS, Patel S, Benjamin RS, Ludwig JA, Conley A, Herzog CE, Anderson P, Meric-Bernstam F, Kurzrock R, Subbiah V. Validation of prognostic scoring and assessment of clinical benefit for patients with bone sarcomas enrolled in phase I clinical trials. Oncotarget. e-Pub 2016. PMID: 27486883.
152. Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong D, Kurzrock R. TP53 Alterations Correlate with Response to VEGF/VEGFR Inhibitors:Implications for Targeted Therapeutics. Mol Cancer Ther. e-Pub 2016. PMID: 27466356.
153. Janku F, Huang HJ, Claes B, Falchook GS, Fu S, Hong D, Ramzanali NM, Nitti G, Cabrilo G, Tsimberidou AM, Naing A, Piha-Paul SA, Wheler JJ, Karp DD, Holley VR, Zinner RG, Subbiah V, Luthra R, Kopetz S, Overman MJ, Kee BK, Patel S, Devogelaere B, Sablon E, Maertens G, Mills GB, Kurzrock R, Meric-Bernstam F. BRAF Mutation Testing in Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics System. Mol Cancer Ther 15(6):1397-404, 2016. e-Pub 2016. PMID: 27207774.
154. Bilen MA, Patel A, Hess KR, Munoz J, Busaidy NL, Wheler JJ, Janku F, Falchook GS, Hong DS, Meric-Bernstam F, Habra MA, Naing A. Association between new-onset hypothyroidism and clinical response in patients treated with tyrosine kinase inhibitor therapy in phase I clinical trials. Cancer Chemother Pharmacol. e-Pub 2016. PMID: 27286994.
155. Hong D, Infante J, Janku F, Jones S, Nguyen LM, Burris H, Naing A, Bauer TM, Piha-Paul S, Johnson FM, Kurzrock R, Golden L, Hynes S, Lin J, Lin AB, Bendell J. Phase I Study of LY2606368, a Checkpoint Kinase 1 Inhibitor, in Patients With Advanced Cancer. J Clin Oncol 34(15):1764-71, 2016. e-Pub 2016. PMID: 27044938.
156. Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner RG, Subbiah V, Fu S, Karp DD, Falchook GS, Tsimberidou AM, Piha-Paul SA, Anderson R, Ke D, Miller VA, Yelensky R, Lee JJ, Hong D, Kurzrock R. Cancer therapy directed by comprehensive genomic profiling: a single center study. Cancer Res. e-Pub 2016. PMID: 27197177.
157. Hou MM, Wang Z, Janku F, Piha-Paul S, Naing A, Hong D, Westin S, Coleman RL, Sood AK, Tsimberidou AM, Subbiah V, Wheler J, Zinner R, Lu K, Meric-Bernstam F, Fu S. Continuous anti-angiogenic therapy after tumor progression in patients with recurrent high-grade epithelial ovarian cancer: phase I trial experience. Oncotarget. e-Pub 2016. PMID: 27147567.
158. Fu S, Culotta KS, Falchook GS, Hong DS, Myers AL, Zhang YP, Naing A, Janku F, Hou MM, Kurzrock R. Erratum to: Pharmacokinetic evaluation of nanoparticle albumin-bound paclitaxel delivered via hepatic arterial infusion in patients with predominantly hepatic metastases. Cancer Chemother Pharmacol 77(4):881, 2016. e-Pub 2016. PMID: 26994910.
159. Khawaja MR, Nick AM, Madhusudanannair V, Fu S, Hong D, McQuinn LM, Ng CS, Piha-Paul SA, Janku F, Subbiah V, Tsimberidou A, Karp D, Meric-Bernstam F, Lu KH, Naing A. Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced/refractory cancers. Cancer Chemother Pharmacol. e-Pub 2016. PMID: 27014780.
160. Liu X, Kambrick S, Fu S, Naing A, Subbiah V, Blumenschein GR, Glisson BS, Kies MS, Tsimberidou AM, Wheler JJ, Zinner RG, Hong DS, Kurzrock R, Piha-Paul SA. Advanced malignancies treated with a combination of the VEGF inhibitor bevacizumab, anti-EGFR antibody cetuximab, and the mTOR inhibitor temsirolimus. Oncotarget. e-Pub 2016. PMID: 26933802.
161. Siqing F, Culotta KS, Falchook GS, Hong DS, Myers AL, Zhang YP, Naing A, Janku F, Hou MM, Kurzrock R. Pharmacokinetic evaluation of nanoparticle albumin-bound paclitaxel delivered via hepatic arterial infusion in patients with predominantly hepatic metastases. Cancer Chemother Pharmacol 77(2):357-64, 2016. e-Pub 2016. PMID: 26698868.
162. Said R, Ye Y, Hong DS, Naing A, Falchook G, Fu S, Wheler JJ, Piha-Paul S, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with 5-fluorouracil, leucovorin, and oxaliplatin in patients with advanced cancer. Cancer Chemother Pharmacol. e-Pub 2016. PMID: 26825327.
163. Fu S, Shi N, Wheler J, Naing A, Janku F, Piha-Paul S, Gong J, Hong D, Tsimberidou A, Zinner R, Subbiah V, Hou M, Ramirez P, Ramondetta L, Lu K, Meric-Bernstam F. Characteristics and outcomes for patients with advanced vaginal or vulvar cancer referred to a phase I clinical trials program: the MD Anderson Cancer Center experience. Gynecologic Oncology Research 2(10):1-6, 2015. e-Pub 2015.
164. Jain RK, Hong DS, Naing A, Wheler J, Helgason T, Shi NY, Gad Y, Kurzrock R. Novel Phase I Study Combining G1 Phase, S Phase, and G2/M Phase Cell Cycle Inhibitors in Patients with Advanced Malignancies. Cell Cycle. e-Pub 2015. PMID: 26467427.
165. Janku F, Angenendt P, Tsimberidou AM, Fu S, Naing A, Falchook GS, Hong DS, Holley VR, Cabrilo G, Wheler JJ, Piha-Paul SA, Zinner RG, Bedikian AY, Overman MJ, Kee BK, Kim KB, Kopetz ES, Luthra R, Diehl F, Meric-Bernstam F, Kurzrock R. Erratum: Actionable mutations in plasma cell-free DNA in patients with advanced cancers referred for experimental targeted therapies. Oncotarget 6(27):24581, 2015. e-Pub 2015. PMID: 26405159.
166. Janku F, Claes B, Huang HJ, Falchook GS, Devogelaere B, Kockx M, Bempt IV, Reijans M, Naing A, Fu S, Piha-Paul SA, Hong DS, Holley VR, Tsimberidou AM, Stepanek VM, Patel SP, Kopetz ES, Subbiah V, Wheler JJ, Zinner RG, Karp DD, Luthra R, Roy-Chowdhuri S, Sablon E, Meric-Bernstam F, Maertens G, Kurzrock R. BRAF mutation testing with a rapid, fully integrated molecular diagnostics system. Oncotarget 6(29):26886-94, 2015. e-Pub 2015. PMID: 26330075.
167. Subbiah IM, Falchook GS, Kaseb AO, Hess KR, Tsimberidou AM, Fu S, Subbiah V, Hong DS, Naing A, Piha-Paul SA, Akmal O, Janku F, Kurzrock R. Exploring response signals and targets in aggressive unresectable hepatocellular carcinoma: an analysis of targeted therapy phase 1 trials. Oncotarget 6(29):28453-62, 2015. e-Pub 2015. PMID: 26164085.
168. Henary H, George GC, Wheler J, Naing A, Piha-Paul S, Fu S, Mistry R, Zinner R, Kurzrock R, Hong DS. A phase 1 study of intermittently administered pazopanib in combination with continuous daily dosing of lapatinib in patients with solid tumors. Cancer Chemother Pharmacol 76(3):597-603, 2015. e-Pub 2015. PMID: 26210681.
169. Seyedin SN, Schoenhals JE, Lee DA, Cortez MA, Wang X, Niknam S, Tang C, Hong DS, Naing A, Sharma P, Allison JP, Chang JY, Gomez DR, Heymach JV, Komaki RU, Cooper LJ, Welsh JW. Strategies for combining immunotherapy with radiation for anticancer therapy. Immunotherapy. e-Pub 2015. PMID: 26310908.
170. Hong DS, Kurzrock R, Wheler JJ, Naing A, Falchook GS, Fu S, Kim KB, Davies MA, Nguyen LM, George GC, Xu L, Shumaker R, Ren M, Mink J, Bedell C, Andresen C, Sachdev P, O'Brien JP, Nemunaitis J. Phase I Dose-Escalation Study of the Multikinase Inhibitor Lenvatinib in Patients with Advanced Solid Tumors and in an Expanded Cohort of Patients with Melanoma. Clin Cancer Res. e-Pub 2015. PMID: 26169970.
171. Busaidy NL, LoRusso P, Lawhorn K, Hess KR, Habra MA, Fu S, Hong DS, Chen HX, Doyle LA, Kurzrock R, Naing A. The Prevalence and Impact of Hyperglycemia and Hyperlipidemia in Patients With Advanced Cancer Receiving Combination Treatment With the Mammalian Target of Rapamycin Inhibitor Temsirolimus and Insulin Growth Factor-Receptor Antibody Cixutumumab. Oncologist. e-Pub 2015. PMID: 26054632.
172. Hong DS, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. Xilonix, a novel true human antibody targeting the inflammatory cytokine interleukin-1 alpha, in non-small cell lung cancer. Invest New Drugs 33(3):621-31, 2015. e-Pub 2015. PMID: 25822109.
173. Fu S, Hou MM, Naing A, Janku F, Hess K, Zinner R, Subbiah V, Hong D, Wheler J, Piha-Paul S, Tsimberidou A, Karp D, Araujo D, Kee B, Hwu P, Wolff R, Kurzrock R, Meric-Bernstam F. Phase I study of Pazopanib and Vorinostat: a Therapeutic Approach for Inhibiting Mutant p53-Mediated Angiogenesis and Facilitating Mutant p53 Degradation. Ann Oncol 26(5):1012-8, 2015. e-Pub 2015. PMID: 25669829.
174. Said R, Kurzrock R, Naing A, Hong DS, Fu S, Piha-Paul SA, Wheler JJ, Janku F, Kee BK, Bidyasar S, Lim J, Wallace M, Tsimberidou AM. Dose-finding study of hepatic arterial infusion of irinotecan-based treatment in patients with advanced cancers metastatic to the liver. Invest New Drugs. e-Pub 2015. PMID: 25990659.
175. Boland GM, Piha-Paul SA, Subbiah V, Routbort M, Herbrich SM, Baggerly K, Patel KP, Brusco L, Horombe C, Naing A, Fu S, Hong DS, Janku F, Johnson A, Broaddus R, Luthra R, Shaw K, Mendelsohn J, Mills GB, Meric-Bernstam F. Clinical next generation sequencing to identify actionable aberrations in a phase I program. Oncotarget. e-Pub 2015. PMID: 26015395.
176. Rodrigues HV, Ke D, Lim J, Stephen B, Bellido J, Janku F, Zinner R, Tsimberidou A, Hong D, Piha-Paul S, Fu S, Naing A, Subbiah V, Karp D, Falchook G, Kurzrock R, Wheler J. Phase I combination of pazopanib and everolimus in PIK3CA mutation positive/PTEN loss patients with advanced solid tumors refractory to standard therapy. Invest New Drugs. e-Pub 2015. PMID: 25902899.
177. Janku F, Angenendt P, Tsimberidou AM, Fu S, Naing A, Falchook GS, Hong DS, Holley VR, Cabrilo G, Wheler JJ, Piha-Paul SA, Zinner RG, Bedikian AY, Overman MJ, Kee BK, Kim KB, Kopetz ES, Luthra R, Diehl F, Meric-Bernstam F, Kurzrock R. Actionable mutations in plasma cell-free DNA in patients with advanced cancers referred for experimental targeted therapies. Oncotarget. e-Pub 2015. PMID: 25980577.
178. Naing A, Dalal S, Abdelrahim M, Wheler J, Hess K, Fu S, Hong DS, Janku F, Falchook GS, Ilustre A, Ouyang F, Kurzrock R. Olanzapine for cachexia in patients with advanced cancer: an exploratory study of effects on weight and metabolic cytokines. Support Care Cancer. e-Pub 2015. PMID: 25680763.
179. Bilen MA, Fu S, Falchook GS, Ng CS, Wheler JJ, Abdelrahim M, Erguvan-Dogan B, Hong DS, Tsimberidou AM, Kurzrock R, Naing A. Phase I trial of valproic acid and lenalidomide in patients with advanced cancer. Cancer Chemother Pharmacol. e-Pub 2015. PMID: 25666183.
180. Tsimberidou AM, Said R, Culotta K, Wistuba I, Jelinek J, Fu S, Falchook G, Naing A, Piha-Paul S, Zinner R, Siddik ZH, He G, Hess K, Stewart DJ, Kurzrock R, Issa JP. Phase I study of azacitidine and oxaliplatin in patients with advanced cancers that have relapsed or are refractory to any platinum therapy. Clin Epigenetics 7(1):29, 2015. e-Pub 2015. PMID: 25806091.
181. Liu X, George GC, Tsimberidou AM, Naing A, Wheler JJ, Kopetz S, Fu S, Piha-Paul SA, Eng C, Falchook GS, Janku F, Garrett C, Karp D, Kurzrock R, Zinner R, Raghav K, Subbiah V, Hess K, Meric-Bernstam F, Hong DS, Overman MJ. Retreatment with anti-EGFR based therapies in metastatic colorectal cancer: impact of intervening time interval and prior anti-EGFR response. BMC Cancer 15(1):713, 2015. e-Pub 2015. PMID: 26474549.
182. Hong DS, Henary H, Falchook GS, Naing A, Fu S, Moulder S, Wheler JJ, Tsimberidou A, Durand JB, Khan R, Yang P, Johansen M, Newman RA, Kurzrock R. First-in-human study of pbi-05204, an oleander-derived inhibitor of akt, fgf-2, nf-κB and p70s6k, in patients with advanced solid tumors. Invest New Drugs 32(6):1204-12, 2014. e-Pub 2014. PMID: 24919855.
183. Hou MM, Liu X, Wheler J, Naing A, Hong D, Coleman RL, Tsimberidou A, Janku F, Zinner R, Lu K, Kurzrock R, Fu S. Targeted PI3K/AKT/mTOR therapy for metastatic carcinomas of the cervix: A phase I clinical experience. Oncotarget 5(22):11168-79, 2014. e-Pub 2014. PMID: 25426553.
184. Falchook GS, Wheler JJ, Naing A, Jackson EF, Janku F, Hong D, Ng CS, Tannir NM, Lawhorn KN, Huang M, Angelo LS, Vishwamitra D, Hess K, Howard AN, Parkhurst KL, Amin HM, Kurzrock R. Targeting hypoxia-inducible factor-1α (HIF-1α) in combination with antiangiogenic therapy: A phase I trial of bortezomib plus bevacizumab. Oncotarget 5(21):10280-92, 2014. e-Pub 2014. PMID: 25373733.
185. Falchook GS, Wheler JJ, Naing A, Piha-Paul SA, Fu S, Tsimberidou AM, Hong DS, Janku F, Zinner R, Jiang Y, Huang M, Lin Q, Parkhurst K, Kurzrock R. Dual antiangiogenic inhibition: a phase I dose escalation and expansion trial targeting VEGF-A and VEGFR in patients with advanced solid tumors. Invest New Drugs. e-Pub 2014. PMID: 25363205.
186. Fontes Jardim DL, Tang C, De Melo-Gagliato D, Falchook GS, Hess KR, Janku F, Fu S, Wheler JJ, Zinner RG, Naing A, Tsimberidou AM, Holla VR, Li MM, Roy Chowdhuri S, Luthra R, Salgia R, Kurzrock R, Meric-Bernstein F, Hong D. Analysis of 1,115 patients tested for MET amplification and therapy response in the MD Anderson Phase I clinic. Clin Cancer Res. e-Pub 2014. PMID: 25326232.
187. Falchook GS, Moulder S, Naing A, Wheler JJ, Hong DS, Piha-Paul SA, Tsimberidou AM, Fu S, Zinner R, Janku F, Jiang Y, Huang M, Parkhurst KL, Kurzrock R. A phase I trial of combination trastuzumab, lapatinib, and bevacizumab in patients with advanced cancer. Invest New Drugs. e-Pub 2014. PMID: 25323060.
188. Falchook GS, Millward M, Hong DS, Naing A, Piha-Paul S, Waguespack SG, Cabanillas M, Sherman SI, Ma B, Curtis M, Goodman V, Kurzrock R. BRAF inhibitor dabrafenib in patients with metastatic BRAF mutant thyroid cancer. Thyroid. e-Pub 2014. PMID: 25285888.
189. Tang C, Hess KR, Fontes Jardim DL, De Melo-Gagliato D, Tsimberidou AM, Falchook G, Fu S, Janku F, Naing A, Piha-Paul SA, Subbiah V, Wheler JJ, Zinner RG, Kurzrock R, Ellis LM, Meric-Bernstam F, Hong D. Synergy between VEGF/VEGFR inhibitors and chemotherapy agents in the phase I clinic. Clin Cancer Res. e-Pub 2014. PMID: 25316815.
190. Ganesan P, Moulder S, Lee JJ, Janku F, Valero V, Zinner RG, Naing A, Fu S, Tsimberidou AM, Hong D, Stephen B, Stephens P, Yelensky R, Meric-Bernstam F, Kurzrock R, Wheler JJ. Triple Negative Breast Cancer Patients Treated at MD Anderson Cancer Center in Phase I Trials: Improved Outcomes with Combination Chemotherapy and Targeted Agents. Mol Cancer Ther. e-Pub 2014. PMID: 25253784.
191. Said R, Ye Y, Falchook GS, Janku F, Naing A, Zinner R, Blumenschein GR, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Kurzrock R, Palmer GA, Aldape K, Hess KR, Tsimberidou AM. Outcomes of patients with advanced cancer and KRAS mutations in phase I clinical trials. Oncotarget. e-Pub 2014. PMID: 25313136.
192. Hassan B, Akcakanat A, Sangai T, Evans KW, Adkins F, Eterovic AK, Zhao H, Chen K, Chen H, Do KA, Xie SM, Holder AM, Naing A, Mills GB, Meric-Bernstam F. Catalytic mTOR inhibitors can overcome intrinsic and acquired resistance to allosteric mTOR inhibitors. Oncotarget. e-Pub 2014. PMID: 25261369.
193. Hong DS, Garrido-Laguna I, Ekmekcioglu S, Falchook GS, Naing A, Wheler JJ, Fu S, Moulder SL, Piha-Paul S, Tsimberidou AM, Wen Y, Culotta KS, Anderes K, Davis DW, Liu W, George GC, Camacho LH, Percy Ivy S, Kurzrock R. Dual inhibition of the vascular endothelial growth factor pathway: A phase 1 trial evaluating bevacizumab and AZD2171 (cediranib) in patients with advanced solid tumors. Cancer 120(14):2164-73, 2014. e-Pub 2014. PMID: 24752867.
194. Tsimberidou AM, Wen S, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul SA, Naing A, Janku F, Aldape KD, Ye Y, Kurzrock R, Berry DA. Personalized Medicine for Patients with Advanced Cancer in the Phase I Program at MD Anderson: Validation and Landmark Analyses. Clin Cancer Res. e-Pub 2014. PMID: 24987059.
195. Corrales-Medina FF, Herzog C, Hess K, Egas-Bejar D, Hong DS, Falchook G, Anderson P, Nunez C, Huh WW, Naing A, Tsimberidou AM, Wheler J, Paul SP, Janku F, Kleinerman ES, Kurzrock R, Subbiah V. Clinical Characteristics and Outcomes of Pediatric Oncology Patients with Aggressive Biology Enrolled in Phase I Clinical Trials Designed for Adults: The University of Texas MD Anderson Cancer Center Experience. Oncoscience 1(7):522-530, 2014. e-Pub 2014. PMID: 25587555.
196. Fu S, Hou MM, Wheler J, Hong D, Naing A, Tsimberidou A, Janku F, Zinner R, Piha-Paul S, Falchook G, Kuo MT, Kurzrock R. Exploratory study of carboplatin plus the copper-lowering agent trientine in patients with advanced malignancies. Invest New Drugs 32(3):465-72, 2014. e-Pub 2014. PMID: 24306314.
197. Said R, Ye Y, Hong DS, Janku F, Fu S, Naing A, Wheler JJ, Kurzrock R, Thomas C, Palmer GA, Hess KR, Aldape K, Tsimberidou AM. Characteristics and survival of patients with advanced cancer and p53 mutations. Oncotarget 5(11):3871-9, 2014. e-Pub 2014. PMID: 25003695.
198. Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Stephens PJ, Kurzrock R. Anastrozole and everolimus in advanced gynecologic and breast malignancies: activity and molecular alterations in the PI3K/AKT/mTOR pathway. Oncotarget 5(10):3029-38, 2014. e-Pub 2014. PMID: 24912489.
199. Bendell JC, Hong DS, Burris HA, Naing A, Jones SF, Falchook G, Bricmont P, Elekes A, Rock EP, Kurzrock R. Phase 1, open-label, dose-escalation, and pharmacokinetic study of STAT3 inhibitor OPB-31121 in subjects with advanced solid tumors. Cancer Chemother Pharmacol. e-Pub 2014. PMID: 24819685.
200. Hou MM, Liu X, Wheler J, Naing A, Hong D, Bodurka D, Schmeler K, Tsimberidou A, Janku F, Zinner R, Piha-Paul S, Hu CY, Lu K, Kurzrock R, Fu S. Outcomes of patients with metastatic cervical cancer in a phase I clinical trials program. Anticancer Res 34(5):2349-55, 2014. e-Pub 2014. PMID: 24778042.
201. Liu X, Lorusso P, Mita M, Piha-Paul S, Hong DS, Fu S, McQuinn L, Asatiani E, Doyle LA, Chen HX, Hess KR, Kurzrock R, Naing A. Incidence of Mucositis in Patients Treated with Temsirolimus-based Regimens and Correlation to Treatment Response. Oncologist 19(4):426-8, 2014. e-Pub 2014. PMID: 24668327.
202. Piha-Paul SA, Wheler JJ, Fu S, Levenback C, Lu K, Falchook GS, Naing A, Hong DS, Tsimberidou AM, Kurzrock R. Advanced gynecologic malignancies treated with a combination of the VEGF inhibitor bevacizumab and the mTOR inhibitor temsirolimus. Oncotarget 5(7):1846-55, 2014. e-Pub 2014. PMID: 24742900.
203. Ganesan P, Piha-Paul S, Naing A, Falchook G, Wheler J, Fu S, Hong DS, Kurzrock R, Janku F, Laday S, Bedikian AY, Kies M, Wolff RA, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with sorafenib in patients with advanced cancer. Invest New Drugs 32(2):279-86, 2014. e-Pub 2014. PMID: 23756764.
204. Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. e-Pub 2014. PMID: 24746841.
205. Bilen MA, Durand JB, McQuinn L, Hess KR, Fu S, Falchook GS, Hong DS, Wheler JJ, Said R, Ewer MS, Kurzrock R, Naing A. Evaluation of a novel blood pressure scoring method and its association with clinical response in cancer patients treated with anti-vascular endothelial growth factor therapy. Invest New Drugs. e-Pub 2014. PMID: 24764123.
206. Wheler JJ, Janku F, Falchook GS, Jackson TL, Fu S, Naing A, Tsimberidou AM, Moulder SL, Hong DS, Yang H, Piha-Paul SA, Atkins JT, Garcia-Manero G, Kurzrock R. Phase I study of anti-VEGF monoclonal antibody bevacizumab and histone deacetylase inhibitor valproic acid in patients with advanced cancers. Cancer Chemother Pharmacol 73(3):495-501, 2014. e-Pub 2014. PMID: 24435060.
207. Tsimberidou AM, Adamopoulos AM, Ye Y, Piha-Paul S, Janku F, Fu S, Hong D, Falchook GS, Naing A, Wheler J, Fortier A, Kurzrock R, Hess KR. Phase I clinical trial of bendamustine and bevacizumab for patients with advanced cancer. J Natl Compr Canc Netw 12(2):194-203, 2014. e-Pub 2014. PMID: 24586081.
208. Naing A, Fu S, Zinner RG, Wheler JJ, Hong DS, Arakawa K, Falchook GS, Kurzrock R. Phase I dose-escalating study of TAS-106 in combination with carboplatin in patients with solid tumors. Invest New Drugs 32(1):154-9, 2014. e-Pub 2014. PMID: 23609829.
209. Janku F, Hong DS, Fu S, Piha-Paul SA, Naing A, Falchook GS, Tsimberidou AM, Stepanek VM, Moulder SL, Lee JJ, Luthra R, Zinner RG, Broaddus RR, Wheler JJ, Kurzrock R. Assessing PIK3CA and PTEN in Early-Phase Trials with PI3K/AKT/mTOR Inhibitors. Cell Rep 6(2):377-87, 2014. e-Pub 2014. PMID: 24440717.
210. Said R, Banchs J, Wheler J, Hess KR, Falchook G, Fu S, Naing A, Hong D, Piha-Paul S, Ye Y, Yeh E, Wolff RA, Tsimberidou AM. The prognostic significance of left ventricular ejection fraction in patients with advanced cancer treated in phase I clinical trials. Ann Oncol 25(1):276-82, 2014. e-Pub 2014. PMID: 24356639.
211. Falchook GS, Naing A, Wheler JJ, Tsimberidou AM, Zinner R, Hong DS, Fu S, Piha-Paul SA, Janku F, Hess KR, Bastida C, Kurzrock R. Dual EGFR inhibition in combination with anti-VEGF treatment in colorectal cancer. Oncoscience 1(8):540-9, 2014. e-Pub 2014. PMID: 25594061.
212. Jiang Y, Subbiah V, Janku F, Ludwig JA, Naing A, Benjamin RS, Brown RE, Anderson P, Kurzrock R. Novel Secondary Somatic Mutations in Ewing's Sarcoma and Desmoplastic Small Round Cell Tumors. PLoS One 9(8):e93676, 2014. e-Pub 2014. PMID: 25119929.
213. Jardim DL, Wheler JJ, Hess K, Tsimberidou AM, Zinner R, Janku F, Subbiah V, Naing A, Piha-Paul SA, Westin SN, Roy-Chowdhuri S, Meric-Bernstam F, Hong DS. FBXW7 mutations in patients with advanced cancers: clinical and molecular characteristics and outcomes with mTOR inhibitors. PLoS One 9(2):e89388, 2014. e-Pub 2014. PMID: 24586741.
214. Tang C, Fontes Jardim DL, Falchook GS, Hess K, Fu S, Wheler JJ, Zinner RG, Naing A, Tsimberidou AM, De Melo Galgiato D, Westin SN, Meric-Bernstam F, Kurzrock R, Hong DS. MET nucleotide variations and amplification in advanced ovarian cancer: characteristics and outcomes with c-Met inhibitors. Oncoscience 1(1):5-13, 2014. e-Pub 2014. PMID: 25593979.
215. Hong DS, Kurzrock R, Naing A, Wheler JJ, Falchook GS, Schiffman JS, Faulkner N, Pilat MJ, O'Brien J, Lorusso P. A phase I, open-label, single-arm, dose-escalation study of E7107, a precursor messenger ribonucleic acid (pre-mRNA) splicesome inhibitor administered intravenously on days 1 and 8 every 21 days to patients with solid tumors. Invest New Drugs. e-Pub 2013. PMID: 24258465.
216. Fu S, McQuinn L, Naing A, Wheler JJ, Janku F, Falchook GS, Piha-Paul SA, Tu D, Howard A, Tsimberidou A, Zinner R, Hong DS, Kurzrock R. Barriers to Study Enrollment in Patients With Advanced Cancer Referred to a Phase I Clinical Trials Unit. Oncologist. e-Pub 2013. PMID: 24153239.
217. Ayala-Ramirez M, Jasim S, Feng L, Ejaz S, Deniz F, Busaidy N, Waguespack SG, Naing A, Sircar K, Wood CG, Pagliaro L, Jimenez C, Vassilopoulou-Sellin R, Habra MA. Adrenocortical carcinoma: clinical outcomes and prognosis of 330 patients at a tertiary care center. Eur J Endocrinol 169(6):891-9, 2013. e-Pub 2013. PMID: 24086089.
218. Tsimberidou AM, Vaklavas C, Fu S, Wen S, Lim JA, Hong D, Wheler J, Naing A, Uehara C, Wallace M, Kurzrock R. Hepatic arterial infusion therapy in advanced cancer and liver-predominant disease: the MD Anderson Experience. Hepatogastroenterology 60(127):1611-23, 2013. e-Pub 2013. PMID: 24634931.
219. Gonzalez-Angulo AM, Meric-Bernstam F, Chawla S, Falchook G, Hong D, Akcakanat A, Chen H, Naing A, Fu S, Wheler J, Moulder S, Helgason T, Li S, Elias I, Desai N, Kurzrock R. Weekly nab-Rapamycin in Patients with Advanced Nonhematologic Malignancies: Final Results of a Phase I Trial. Clin Cancer Res 19(19):5474-84, 2013. e-Pub 2013. PMID: 24089446.
220. Ganesan P, Janku F, Naing A, Hong DS, Tsimberidou AM, Falchook GS, Wheler JJ, Piha-Paul SA, Fu S, Stepanek VM, Lee JJ, Luthra R, Overman MJ, Kopetz S, Wolff RA, Kurzrock R. Target-Based Therapeutic Matching in Early-Phase Clinical Trials in Patients with Advanced Colorectal Cancer and PIK3CA mutations. Mol Cancer Ther. e-Pub 2013. PMID: 24092809.
221. Henary H, Hong DS, Falchook GS, Tsimberidou A, George GC, Wen S, Wheler J, Fu S, Naing A, Piha-Paul S, Janku F, Kim KB, Hwu P, Kurzrock R. Melanoma patients in a phase I clinic: molecular aberrations, targeted therapy and outcomes. Ann Oncol 24(8):2158-65, 2013. e-Pub 2013. PMID: 23576709.
222. Ganesan P, Piha-Paul S, Naing A, Falchook G, Wheler J, Janku F, Zinner R, Laday S, Kies M, Tsimberidou AM. Phase I clinical trial of lenalidomide in combination with temsirolimus in patients with advanced cancer. Invest New Drugs. e-Pub 2013. PMID: 23982248.
223. Naing A, Cohen R, Dy GK, Hong DS, Dyster L, Hangauer DG, Kwan R, Fetterly G, Kurzrock R, Adjei AA. A phase I trial of KX2-391, a novel non-ATP competitive substrate-pocket- directed SRC inhibitor, in patients with advanced malignancies. Invest New Drugs 31(4):967-73, 2013. e-Pub 2013. PMID: 23361621.
224. Hong DS, Choe JH, Naing A, Wheler JJ, Falchook GS, Piha-Paul S, Moulder SL, George GC, Choe JM, Strauss LC, Gallick GE, Kurzrock R. A phase 1 study of gemcitabine combined with dasatinib in patients with advanced solid tumors. Invest New Drugs 31(4):918-26, 2013. e-Pub 2013. PMID: 23179336.
225. Falchook GS, Fu S, Naing A, Hong DS, Hu W, Moulder S, Wheler JJ, Sood AK, Bustinza-Linares E, Parkhurst KL, Kurzrock R. Methylation and histone deacetylase inhibition in combination with platinum treatment in patients with advanced malignancies. Invest New Drugs. e-Pub 2013. PMID: 23907406.
226. Wheler JJ, Tsimberidou AM, Falchook GS, Zinner RG, Hong DS, Fok JY, Fu S, Piha-Paul SA, Naing A, Kurzrock R. Combining erlotinib and cetuximab is associated with activity in patients with non-small cell lung cancer (including squamous cell carcinomas) and wild-type EGFR or resistant mutations. Mol Cancer Ther. e-Pub 2013. PMID: 23963360.
227. Veasey-Rodrigues H, Parsons HA, Janku F, Naing A, Wheler JJ, Tsimberidou AM, Kurzrock R. A pilot study of temsirolimus and body composition. J Cachexia Sarcopenia Muscle. e-Pub 2013. PMID: 23893509.
228. Hong DS, Said R, Falchook GS, Naing A, Moulder SL, Tsimberidou AM, Galluppi G, Dakappagari N, Storgard C, Kurzrock R, Rosen LS. Phase I study of BIIB028, a selective heat shock protein 90 inhibitor, in patients with refractory metastatic or locally advanced solid tumors. Clin Cancer Res. e-Pub 2013. PMID: 23873691.
229. Veasey Rodrigues H, Baracos VE, Wheler JJ, Parsons HA, Hong DS, Naing A, Fu S, Falchook G, Tsimberidou AM, Piha-Paul S, Chisholm G, Kurzrock R. Body composition and survival in the early clinical trials setting. Eur J Cancer. e-Pub 2013. PMID: 23867127.
230. Jiang Y, Janku F, Subbiah V, Angelo LS, Naing A, Anderson PM, Herzog CE, Fu S, Benjamin RS, Kurzrock R. Germline PTPRD mutations in Ewing Sarcoma: Biologic and clinical implications. Oncotarget. e-Pub 2013. PMID: 23800680.
231. Wheler J, Hong D, Swisher SG, Falchook G, Tsimberidou AM, Helgason T, Naing A, Stephen B, Janku F, Stephens PJ, Yelensky R, Kurzrock R. Thymoma patients treated in a phase I clinic at MD Anderson Cancer Center: Responses to mTOR inhibitors and molecular analyses. Oncotarget 4(6):890-8, 2013. e-Pub 2013. PMID: 23765114.
232. Wheler J, Falchook G, Tsimberidou AM, Hong D, Naing A, Piha-Paul S, Chen SS, Heymach J, Fu S, Stephen B, Fok JY, Janku F, Kurzrock R. Revisiting clinical trials using EGFR inhibitor-based regimens in patients with advanced non-small cell lung cancer: A retrospective analysis of an MD Anderson Cancer Center phase I population. Oncotarget 4(5):772-84, 2013. e-Pub 2013. PMID: 23800712.
233. Kurzrock R, Atkins J, Wheler J, Fu S, Naing A, Busaidy N, Hong D, Sherman S. Tumor marker and measurement fluctuations may not reflect treatment efficacy in patients with medullary thyroid carcinoma on long-term RET inhibitor therapy. Ann Oncol. e-Pub 2013. PMID: 23676418.
234. Said R, Hong DS, Warneke CL, Lee JJ, Wheler JJ, Janku F, Naing A, Falchook GS, Fu S, Piha-Paul S, Tsimberidou AM, Kurzrock R. P53 mutations in advanced cancers: clinical characteristics, outcomes, and correlation between progression-free survival and bevacizumab-containing therapy. Oncotarget. e-Pub 2013. PMID: 23670029.
235. Naing A, Lorusso P, Fu S, Hong D, Chen HX, Doyle LA, Phan AT, Habra MA, Kurzrock R. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. Br J Cancer 108(4):826-30, 2013. e-Pub 2013. PMID: 23412108.
236. Tsimberidou AM, Ye Y, Wheler J, Naing A, Hong D, Nwosu U, Hess KR, Wolff RA. A phase I study of hepatic arterial infusion of nab-paclitaxel in combination with intravenous gemcitabine and bevacizumab for patients with advanced cancers and predominant liver metastases. Cancer Chemother Pharmacol. e-Pub 2013. PMID: 23377373.
237. Naing A, Kurzrock R. Dodging a dogma: is treating beyond progression beneficial?. Cancer Chemother Pharmacol. e-Pub 2013. PMID: 23443308.
238. Janku F, Wheler JJ, Naing A, Falchook GS, Hong DS, Stepanek VM, Fu S, Piha-Paul SA, Lee JJ, Luthra R, Tsimberidou AM, Kurzrock R. PIK3CA Mutation H1047R is Associated with Response to PI3K/AKT/mTOR Signaling Pathway Inhibitors in Early-Phase Clinical Trials. Cancer Res 73(1):276-84, 2013. e-Pub 2013. PMID: 23066039.
239. Falchook GS, Naing A, Hong DS, Zinner R, Fu S, Piha-Paul SA, Tsimberidou AM, Morgan-Linnell SK, Jiang Y, Bastida C, Wheler JJ, Kurzrock R. Dual EGFR inhibition in combination with anti-VEGF treatment: A phase I clinical trial in non-small cell lung cancer. Oncotarget 4(1):118-27, 2013. e-Pub 2013. PMID: 23435217.
240. Subbiah IM, Subbiah V, Tsimberidou AM, Naing A, Kaseb AO, Javle M, Fu S, Hong DS, Piha-Paul S, Wheler JJ, Hess KR, Janku F, Falchook GS, Wolff RA, Kurzrock R. Targeted therapy of advanced gallbladder cancer and cholangiocarcinoma with aggressive biology: eliciting early response signals from phase 1 trials. Oncotarget 4(1):156-65, 2013. e-Pub 2013. PMID: 23391555.
241. Naing A, Agarwal R, Falchook G, Hong DS, Janku F, Wheler J, Fu S, Kurzrock R. Retreatment after secondary resistance or mixed response: a pilot study. Oncology 85(6):350-5, 2013. e-Pub 2013. PMID: 24335388.
242. Abdelrahim M, Matsuda A, Naing A. TAS-106: Preclinical, Clinical and Beyond. Oncology 85(6):356-63, 2013. e-Pub 2013. PMID: 24335431.
243. Janku F, Wheler JJ, Naing A, Stepanek VM, Falchook GS, Fu S, Garrido-Laguna I, Tsimberidou AM, Piha-Paul SA, Moulder SL, Lee JJ, Luthra R, Hong DS, Kurzrock R. PIK3CA mutations in advanced cancers: characteristics and outcomes. Oncotarget 3(12):1566-75, 2012. e-Pub 2012. PMID: 23248156.
244. Hong DS, Patel JC, Wheler J, Naing A, Garrido-Laguna I, Falchook G, Fu S, Tsimberidou AM, Kopetz S, Win S, Kurzrock R. Outcomes in 144 patients with colorectal cancer treated in a phase I clinic: The MD Anderson Cancer Center Experience. Clin Colorectal Cancer 11(4):297-303, 2012. e-Pub 2012. PMID: 22537607.
245. Wheler JJ, Falchook GS, Tsimberidou AM, Hong DS, Naing A, Piha-Paul SA, Chen SS, Fu S, Stephen B, Fok JY, Janku F, Kurzrock R. Aberrations in the epidermal growth factor receptor gene in 958 patients with diverse advanced tumors: implications for therapy. Ann Oncol. e-Pub 2012. PMID: 23139256.
246. Tsimberidou AM, Leick MB, Lim J, Fu S, Wheler J, Piha-Paul SA, Hong D, Falchook GS, Naing A, Subbiah IM, Fortier A, Avritscher R, Kurzrock R. Dose-finding study of hepatic arterial infusion of oxaliplatin-based treatment in patients with advanced solid tumors metastatic to the liver. Cancer Chemother Pharmacol. e-Pub 2012. PMID: 23143207.
247. Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul S, Naing A, Janku F, Luthra R, Ye Y, Wen S, Berry D, Kurzrock R. Personalized medicine in a phase i clinical trials program: The MD Anderson Cancer Center Initiative. Clin Cancer Res 18(22):6373-83, 2012. e-Pub 2012. PMID: 22966018.
248. Naing A, Veasey-Rodrigues H, Hong DS, Fu S, Falchook GS, Wheler JJ, Tsimberidou AM, Wen S, Fessahaye SN, Golden EC, Aaron J, Ewer MS, Kurzrock R. Electrocardiograms (ECGs) in phase I anti-cancer drug development: the MD Anderson Cancer Center experience with 8518 ECGs. Ann Oncol 23(11):2960-3, 2012. e-Pub 2012. PMID: 22745218.
249. Moroney J, Fu S, Moulder S, Falchook G, Helgason T, Levenback C, Hong D, Naing A, Wheler J, Kurzrock R. Phase I study of the anti-angiogenic antibody bevacizumab and the mTOR / hypoxia-inducible factor inhibitor temsirolimus combined with liposomal doxorubicin. Clin Cancer Res 18(20):5796-805, 2012. e-Pub 2012. PMID: 22927482.
250. Naing A, Aghajanian C, Raymond E, Olmos D, Schwartz G, Oelmann E, Grinsted L, Burke W, Taylor R, Kaye S, Kurzrock R, Banerji U. Safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8055 in advanced solid tumours and lymphoma. Br J Cancer 107(7):1093-9, 2012. e-Pub 2012. PMID: 22935583.
251. Fu S, Barber FD, Naing A, Wheler J, Hong D, Falchook G, Piha-Paul S, Tsimberidou A, Howard A, Kurzrock R. Advance care planning in patients with cancer referred to a phase i clinical trials program: the MD Anderson Cancer Center Experience. J Clin Oncol 30(23):2891-6, 2012. e-Pub 2012. PMID: 22778314.
252. Wheler JJ, Tsimberidou AM, Hong DS, Naing A, Falchook GS, Fu S, Moulder S, Stephen B, Wen S, Kurzrock R. Risk of serious toxicity in 1181 patients treated in phase I clinical trials of predominantly targeted anticancer drugs: The MD Anderson Cancer Center Experience. Ann Oncol 23(8):1963-7, 2012. e-Pub 2012. PMID: 22377564.
253. Tsimberidou AM, Fu S, Subbiah IM, Naing A, Hong DS, Wen S, Fortier AH, Lim J, Kurzrock R. Intraperitoneal and intravenous chemotherapy in peritoneal carcinomatosis. Hepatogastroenterology 59(116):960-4, 2012. e-Pub 2012. PMID: 22580643.
254. Hong DS, Kurzrock R, Supko JG, He X, Naing A, Wheler J, Lawrence D, Eder JP, Meyer CJ, Ferguson DA, Mier J, Konopleva M, Konoplev S, Andreeff M, Kufe D, Lazarus H, Shapiro GI, Dezube BJ. A phase I first-in-human trial of bardoxolone methyl in patients with advanced solid tumors and lymphomas. Clin Cancer Res 18(12):3396-3406, 2012. e-Pub 2012. PMID: 22634319.
255. Munoz J, Naing A, Qi M, Kurzrock R. Cutaneous Castleman disease. Br J Haematol 157(6):652, 2012. e-Pub 2012. PMID: 22533925.
256. Fu S, Naing A, Fu C, Kuo MT, Kurzrock R. Overcoming platinum resistance through the use of a copper-lowering agent. Mol Cancer Ther 11(6):1221-5, 2012. e-Pub 2012. PMID: 22491798.
257. Jain RK, Lee JJ, Ng C, Hong D, Gong J, Naing A, Wheler J, Kurzrock R. Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies. J Clin Oncol. e-Pub 2012. PMID: 22689801.
258. Falchook GS, Duvic M, Hong DS, Wheler J, Naing A, Lim J, Kurzrock R. Age-stratified phase I trial of a combination of bortezomib, gemcitabine, and liposomal doxorubicin in patients with advanced malignancies. Cancer Chemother Pharmacol 69(5):1117-26, 2012. e-Pub 2012. PMID: 22205203.
259. Wheler J, Tsimberidou AM, Hong D, Naing A, Falchook G, Piha-Paul S, Fu S, Moulder S, Stephen B, Wen S, Kurzrock R. Survival of 1,181 patients in a phase I clinic: the MD Anderson Clinical Center for Targeted Therapy experience. Clin Cancer Res 18(10):2922-9, 2012. e-Pub 2012. PMID: 22452943.
260. Naing A, LoRusso P, Fu S, Hong DS, Anderson P, Benjamin RS, Ludwig J, Chen HX, Doyle LA, Kurzrock R. Insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with refractory Ewing's Sarcoma family tumors. Clin Cancer Res 18(9):2625-31, 2012. e-Pub 2012. PMID: 22465830.
261. Janku F, Wheler JJ, Westin SN, Moulder SL, Naing A, Tsimberidou AM, Fu S, Falchook GS, Hong DS, Garrido-Laguna I, Luthra R, Lee JJ, Lu KH, Kurzrock R. PI3K/AKT/mTOR inhibitors in patients with breast and gynecologic malignancies harboring PIK3CA mutations. J Clin Oncol 30(8):777-82, 2012. e-Pub 2012. PMID: 22271473.
262. Garrido-Laguna I, Janku F, Vaklavas C, Falchook GS, Fu S, Hong DS, Naing A, Tsimberidou AM, Wen S, Kurzrock R. Validation of the Royal Marsden Hospital prognostic score in patients treated in the phase I clinical trials program at the MD Anderson Cancer Center. Cancer 118(5):1422-8, 2012. e-Pub 2012. PMID: 21823111.
263. Naing A, Kurzrock R, Adams LM, Kleha JF, Laubscher KH, Bonate PL, Weller S, Fitzgerald C, Xu Y, LoRusso PM. A comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in patients with solid tumors. Invest New Drugs 30(1):327-34, 2012. e-Pub 2012. PMID: 20842406.
264. Garrido-Laguna I, Hong DS, Janku F, Nguyen LM, Falchook GS, Fu S, Wheler JJ, Luthra R, Naing A, Wang X, Kurzrock R. KRASness and PIK3CAness in Patients with Advanced Colorectal Cancer: Outcome after Treatment with Early-Phase Trials with Targeted Pathway Inhibitors. PLoS One 7(5):e38033, 2012. e-Pub 2012. PMID: 22675430.
265. Moroney JW, Schlumbrecht MP, Helgason T, Coleman RL, Moulder S, Naing A, Bodurka DC, Janku F, Hong DS, Kurzrock R. A phase I trial of liposomal Doxorubicin, bevacizumab, and temsirolimus in patients with advanced gynecologic and breast malignancies. Clin Cancer Res 17(21):6840-6, 2011. e-Pub 2011. PMID: 21890452.
266. Naing A, Stephen SK, Frenkel M, Chandhasin C, Hong DS, Lei X, Falchook G, Wheler JJ, Fu S, Kurzrock R. Prevalence of complementary medicine use in a phase 1 clinical trials program: The MD Anderson Cancer Center Experience. Cancer 117(22):5142-50, 2011. e-Pub 2011. PMID: 21538342.
267. Hong DS, Kurzrock R, Oh Y, Wheler J, Naing A, Brail L, Callies S, André V, Kadam SK, Nasir A, Holzer TR, Meric-Bernstam F, Fishman M, Simon G. A phase I dose-escalation, pharmacokinetic, and pharmacodynamic evaluation of eIF-4E antisense oligonucleotide LY227596 in patients with advanced cancer. Clin Cancer Res 17(20):6582-91, 2011. e-Pub 2011. PMID: 21831956.
268. Naing A, Kurzrock R, Burger A, Gupta S, Lei X, Busaidy N, Hong D, Chen HX, Doyle LA, Heilbrun LK, Rohren E, Ng C, Chandhasin C, LoRusso P. Phase I trial of cixutumumab combined with temsirolimus in patients with advanced cancer. Clin Cancer Res 17(18):6052-60, 2011. e-Pub 2011. PMID: 21750201.
269. Fu S, Hong DS, Naing A, Wheler J, Falchook G, Wen S, Howard A, Barber D, Nates J, Price K, Kurzrock R. Outcome analyzes after the first admission to an intensive care unit in patients with advanced cancer referred to a phase I clinical trials program. J Clin Oncol 29(26):3547-52, 2011. e-Pub 2011. PMID: 21844494.
270. Fu S, Naing A, Moulder SL, Culotta KS, Madoff DC, Ng CS, Madden TL, Falchook GS, Hong DS, Kurzrock R. Phase I trial of hepatic arterial infusion of nanoparticle albumin-bound paclitaxel: toxicity, pharmacokinetics, and activity. Mol Cancer Ther 10(7):1300-7, 2011. e-Pub 2011. PMID: 21571911.
271. Hong DS, Cabanillas ME, Wheler J, Naing A, Tsimberidou AM, Ye L, Waguespack SG, Hernandez M, El Naggar AK, El Naggar AK, Bidyasar S, Wright J, Sherman SI, Kurzrock R, Busaidy NL. Inhibition of the Ras/Raf/MEK/ERK and RET Kinase pathways with the combination of the multikinase inhibitor sorafenib and the farnesyltransferase inhibitor tipifarnib in medullary and differentiated thyroid malignancies. J Clin Endocrinol Metab 96(4):997-1005, 2011. e-Pub 2011. PMID: 21289252.
272. Tsimberidou AM, Letourneau K, Wen S, Wheler JJ, Hong DS, Naing A, Iskander NG, Uehara C, Kurzrock R. Phase I clinical trials in 93 patients with brain metastases: The MD Anderson Cancer Center Experience. Clin Cancer Res. e-Pub 2011. PMID: 21415223.
273. Janku F, Tsimberidou AM, Garrido-Laguna I, Wang X, Luthra R, Hong DS, Naing A, Falchook GS, Moroney JW, Piha-Paul SA, Wheler JJ, Moulder SL, Fu S, Kurzrock R. PIK3CA mutations in patients with advanced cancers treated with PI3K/AKT/mTOR axis inhibitor. Mol Cancer Ther 10(3):558-65, 2011. e-Pub 2011. PMID: 21216929.
274. Naing A, Reuben JM, Camacho LH, Gao H, Lee BN, Cohen EN, Verschraegen C, Stephen S, Aaron J, Hong D, Wheler J, Kurzrock R. Phase I Dose Escalation Study of Sodium Stibogluconate (SSG), a Protein Tyrosine Phosphatase Inhibitor, Combined with Interferon Alpha for Patients with Solid Tumors. j Cancer 10(2):81-89, 2011. e-Pub 2011.
275. Vaklavas C, Tsimberidou AM, Wen S, Hong D, Wheler J, Ng CS, Naing A, Uehara C, Wolff RA, Kurzrock R. Phase I clinical trials in 83 patients with pancreatic cancer: the MD Anderson Cancer Center experience. Cancer 117(1):77-85, 2011. e-Pub 2011. PMID: 20737567.
276. Janku F, Tsimberidou AM, Wang X, Hong DS, Naing A, Gong J, Garrido-Laguna I, Parsons HA, Zinner RG, Kurzrock R. Outcomes of patients with advanced non-small cell lung cancer treated in a phase I clinic. Oncologist 16(3):327-35, 2011. e-Pub 2011. PMID: 21339262.
277. Ludwig JA, Lamhamedi-Cherradi SE, Lee HY, Naing A, Benjamin R. Dual targeting of the insulin-like growth factor and collateral pathways in cancer: combating drug resistance. Cancers (Basel) 3(3):3029-54, 2011. e-Pub 2011. PMID: 24212944.
278. El-Osta H, Falchook G, Tsimberidou A, Hong D, Naing A, Kim K, Wen S, Janku F, Kurzrock R. BRAF mutations in advanced cancers: clinical characteristics and outcomes. PLoS One 6(10):e25806, 2011. e-Pub 2011. PMID: 22039425.
279. Janku F, Lee JJ, Tsimberidou AM, Hong DS, Naing A, Falchook GS, Fu S, Luthra R, Garrido-Laguna I, Kurzrock R. PIK3CA mutations frequently coexist with RAS and BRAF mutations in patients with advanced cancers. PLoS One 6(7):e22769, 2011. e-Pub 2011. PMID: 21829508.
280. Subbiah V, Naing A, Brown RE, Chen H, Doyle L, LoRusso P, Benjamin R, Anderson P, Kurzrock R. Targeted morphoproteomic profiling of Ewing's Sarcoma treated with insulin-like growth factor 1 receptor (IGF1R) inhibitors: response/resistance signatures. PLoS One 6(4):e18424, 2011. e-Pub 2011. PMID: 21494688.
281. El-Osta H, Hong D, Wheler J, Fu S, Naing A, Falchook G, Hicks M, Wen S, Tsimberidou AM, Kurzrock R. Outcomes of research biopsies in phase I clinical trials: the MD Anderson Cancer Center Experience. Oncologist 16(9):1292-8, 2011. e-Pub 2011. PMID: 21859821.
282. Tsimberidou AM, Moulder S, Fu S, Wen S, Naing A, Bedikian AY, Daring S, Uehara C, Ng C, Wallace M, Camacho L, Kurzrock R. Phase 1 clinical trial of hepatic arterial infusion of cisplatin in combination with intravenous liposomal doxorubicin in patients with advanced cancer and dominant liver involvement. Cancer Chemother Pharmacol 66(6):1087-93, 2010. e-Pub 2010. PMID: 20204368.
283. Tsimberidou AM, Letourneau K, Fu S, Hong D, Naing A, Wheler J, Uehara C, McRae SE, Wen S, Kurzrock R. Phase I clinical trial of hepatic arterial infusion of paclitaxel in patients with advanced cancer and dominant liver involvement. Cancer Chemother Pharmacol. e-Pub 2010. PMID: 20941597.
284. Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with advanced breast, non-small cell lung and prostate cancer. Invest New Drugs 28(5):634-40, 2010. e-Pub 2010. PMID: 19499186.
285. Garrido-Laguna I, Janku F, Falchook GS, Fu S, Hong DS, Naing A, Aaron J, Wang X, Kies M, Kurzrock R. Patients with advanced head and neck cancers have similar progression-free survival on phase I trials and their last FDA-approved treatment. Clin Cancer Res 16(15):4031-7, 2010. e-Pub 2010. PMID: 20525754.
286. Moroney J, Wheler J, Hong D, Naing A, Falchook G, Bodurka D, Coleman R, Lu K, Xiao L, Kurzrock R. Phase I clinical trials in 85 patients with gynecologic cancer: the MD Anderson Cancer Center experience. Gynecol Oncol 117(3):467-72, 2010. e-Pub 2010. PMID: 20347123.
287. Jain RK, Lee JJ, Hong D, Markman M, Gong J, Naing A, Wheler J, Kurzrock R. Phase 1 oncology studies: evidence that in the era of targeted therapies patients on lower doses do not fare worse. Clin Cancer Res 16(1289-97):1289-97, 2010. e-Pub 2010. PMID: 20145187.
288. Wheler J, Tsimberidou AM, Moulder S, Cristofanilli M, Hong D, Naing A, Pathak R, Liu S, Feng L, Kurzrock R. Clinical outcomes of patients with breast cancer in a phase I clinic: the MD Anderson Cancer Center experience. Clin Breast Cancer 10(46-51):46-51, 2010. e-Pub 2010. PMID: 20133258.
289. Hong DS, Sebti SM, Newman RA, Blaskovich MA, Ye L, Gagel RF, Moulder S, Wheler JJ, Naing A, Tannir NM, Ng CS, Sherman SI, El Naggar AK, Khan R, Trent J, Wright JJ, Kurzrock R. Phase I trial of a combination of the multikinase inhibitor sorafenib and the farnesyltransferase inhibitor tipifarnib in advanced malignancies. Clin Cancer Res 15(7061-8):7061-8, 2009. e-Pub 2009. PMID: 19903778.
290. Tsimberidou AM, Vaklavas C, Wen S, Hong D, Wheler J, Ng C, Naing A, Tse S, Busaidy N, Markman M, Sherman SI, Kurzrock R. Phase I clinical trials in 56 patients with thyroid cancer: The MD Anderson Cancer Center experience. J Clin Endocrinol Metab 94(4423-32):4423-32, 2009. e-Pub 2009. PMID: 19820016.
291. Wheler J, Tsimberidou AM, Hong D, Naing A, Jackson T, Liu S, Feng L, Kurzrock R. Survival of patients in a phase I clinic: The MD Anderson Cancer Center experience. Cancer 115(1091-9):1091-9, 2009. e-Pub 2009. PMID: 19165805.
292. Nakamura R, Rodriguez R, Palmer J, Stein A, Naing A, Tsai N, Chang K, Slovak ML, Bhatia R, Spielberger R, Kogut N, Pullarkat V, Kirschbaum M, Forman SJ, O'Donnell MR. Reduced-intensity conditioning for allogeneic hematopoietic stem cell transplantation with fludarabine and melphalan is associated with durable disease control in myelodysplastic syndrome. Bone Marrow Transplant 40(9):843-850, 2007. e-Pub 2007. PMID: 17724447.

Invited Articles

1. Naing A. A new screening tool for FGFR inhibitor treatment?. Lancet Oncol(10):1340-1342, 2019. e-Pub 2019.

Other Articles

1. de Miguel-Perez, D, Ak, M, Mamindla, P, Russo, A, Zenkin, S, Ak, N, Peddagangireddy, V, Lara‑Mejia, L, Gunasekaran, M, Cardona, AF, Naing, A, Hirsch, F, Arrieta, O, Colen, R, Rolfo, C Validation of a multiomic model of plasma extracellular vesicle PD-L1 and radiomics for prediction of response to immunotherapy in NSCLC. Journal of Experimental and Clinical Cancer Research 43(1), 2024. PMID: 38486328.
2. Kim, ST, Chu, Y, Misoi, MW, Suarez-Almazor, M, Tayar, JH, Lu, H, Buni, M, Kramer, J, Rodriguez, E, Hussain, Z, Neelapu, SS, Wang, RJ, Shah, AY, Tannir, NM, Campbell, M, Gibbons, DL, Cascone, T, Lu, C, Blumenschein, GR, Altan, M, Lim, B, Valero, V, Loghin, ME, Tu, J, Westin, SN, Naing, A, Garcia-Manero, G, Hassan, NA, Tawbi, H, Hwu, P, Oliva, IC, Davies, MA, Patel, SP, Zou, J, Futreal, A, Diab, A, Wang, L, Nurieva, R Author Correction. Nature communications 15(1), 2024. PMID: 38965214.
3. Salkeni MA, Naing A Interleukin-10 in cancer immunotherapy: from bench to bedside. Trends Cancer 9(9):716-725, 2023. PMID: 37321942.
4. Alhalabi O, Groisberg R, Zinner R, Hahn AW, Naing A, Zhang S, Tsimberidou AM, Rodon J, Fu S, Yap TA, Hong DS, Sun M, Jiang Y, Pant S, Shah AY, Zurita A, Tannir NM, Vikram R, Roszik J, Meric-Bernstam F, Subbiah V Phase I study of sapanisertib with carboplatin and paclitaxel in mTOR pathway altered solid malignancies. NPJ Precis Oncol 7(1):37, 2023. PMID: 37072571.
5. Rolfo C, Giovannetti E, Martinez P, McCue S, Naing A Applications and clinical trial landscape using Toll-like receptor agonists to reduce the toll of cancer. NPJ Precis Oncol 7(1):26, 2023. PMID: 36890302.
6. Adashek JJ, Subbiah V, Westphalen CB, Naing A, Kato S, Kurzrock R Cancer: slaying the nine-headed Hydra. Ann Oncol 34(1):61-69, 2023. PMID: 35931318.
7. Nelson BE, Ejezie CL, Stephen BA, Nardo M, Campbell E, Gong J, Hong DS, Fu S, Yap TA, Murphy MB, Piha-Paul S, Daver NG, Rojas-Hernandez CM, Naing A Spectrum of Immune Checkpoint Inhibitor Anemias: Results From a Single Center, Early-Phase Clinical Trials Case Series Experience. J Hematol 11(3):113-120, 2022. PMID: 35837373.
8. Yao S, Meric-Bernstam F, Hong D, Janku F, Naing A, Piha-Paul SA, Tsimberidou AM, Karp D, Subbiah V, Yap TA, Ahnert JR, Pant S, Dumbrava EEI, Wathoo C, Campbell E, Yu L, Yamamura Y, Fu S Clinical characteristics and outcomes of phase I cancer patients with CCNE1 amplification: MD Anderson experiences. Sci Rep 12(1):8701, 2022. PMID: 35610322.
9. Srivastava A, Nogueras Gonzalez GM, Geng Y, Won AM, Cabanillas ME, Naing A, Myers JN, Li Y, Chambers MS Prevalence of medication related osteonecrosis of the jaw in patients treated with sequential antiresorptive drugs: systematic review and meta-analysis. Support Care Cancer 29(5):2305-2317, 2021. PMID: 33190182.
10. Piha-Paul SA, Dumbrava EE, Nair BC, Xiong W, Xu L, Mostorino R, Subbiah V, Tannir N, Fu S, Naing A, Janku F, Karp DD, Patel S, Daw NC, Hong D, Meric-Bernstam F, Zinner R A Phase I Trial of the MET/ALK/ROS1 Inhibitor Crizotinib Combined with the VEGF Inhibitor Pazopanib in Patients with Advanced Solid Malignancies. Onco Targets Ther 14:3037-3049, 2021. PMID: 33994796.
11. Choi Y, Shi Y, Haymaker CL, Naing A, Ciliberto G, Hajjar J T-cell agonists in cancer immunotherapy. J Immunother Cancer 8(2), 2020. PMID: 33020242.
12. Porta R, Borea R, Coelho A, Khan S, Araújo A, Reclusa P, Franchina T, Van Der Steen N, Van Dam P, Ferri J, Sirera R, Naing A, Hong D, Rolfo C FGFR a promising druggable target in cancer: Molecular biology and new drugs. Crit Rev Oncol Hematol 113:256-267, 2017. PMID: 28427515.
13. Bupathi M, Kaseb A, Meric-Bernstam F, Naing A Hepatocellular carcinoma: Where there is unmet need. Mol Oncol 9(8):1501-9, 2015. PMID: 26160430.
14. Moon YW, Hajjar J, Hwu P, Naing A Targeting the indoleamine 2,3-dioxygenase pathway in cancer. J Immunother Cancer 3:51, 2015. PMID: 26674411.
15. Tang C, Wang X, Soh H, Seyedin S, Cortez MA, Krishnan S, Massarelli E, Hong D, Naing A, Diab A, Gomez D, Ye H, Heymach J, Komaki R, Allison JP, Sharma P, Welsh JW Combining Radiation and Immunotherapy: A New Systemic Therapy for Solid Tumors?. Cancer Immunol Res 2(9):831-838, 2014. PMID: 25187273.
16. Naing A, Kurzrock R Chemotherapy Resistance and Retreatment: A Dogma Revisited (case report). Clin Colorectal Cancer 9(2):E 1-4, 2010. PMID: 20378496.
17. Naing A, Sokol L, List AF Developmental therapeutics for myelodysplastic syndromes. J Natl Compr Canc Netw 4(1):78-82, 2006. PMID: 16403406.
18. Naing A, Luong D, Extermann M Methotrexate-induced status epilepticus. Am J Hematol 80(1):35-37, 2005. PMID: 16138356.
19. Naing A, Messina JL, Vrionis FR, Daud AI Uncommon manifestations of common malignancies: Case 3. Malignant melanoma arising from a spinal nerve root. J Clin Oncol 22(15):3194-3195, 2004. PMID: 15284274.
20. Soto-Lanza F, Glick L, Chan C, Zhong L, Wilson N, Faiz S, Gandhi S, Naing A, Heymach JV, Shannon VR, Franco-Vega M, Liao Z, Lin SH, Palaskas NL, Wu J, Shroff GS, Altran M, Sheshadri A Long-Term Clinical, Radiological, and Mortality Outcomes Following Pneumonitis in Nonsmall Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Analysis. Clin Lung Cancer. PMID: 39183094.
21. Curigilano G, Curigliano H, Mach N, Doi T, Tai D, Forde PM, Sarantopoulos J, Bedard PL, Lin CC, Hodi FS, Wilgenhof S, Santoro A, Sabatos-Peyton CA, Longmire TA, Xyrafas A, Sun H, Gutzwiller S, Manenti L, Naing A Correction: Phase I/Ib Clinical Trial of Sabatolimab, an Anti-TIM-3 Antibody, Alone and in Combination with Spartalizumab, an Anti-PD-1 Antibody, in Advanced Solid Tumors. PMID: 39224022.

Editorials

1. Naing A. Being realistic and optimistic in curing cancer. J Immunother Precis Oncol 1:53-55, 2018.
2. Hajjar J, Habra MA, Naing A. Metformin: an old drug with new potential. Expert Opin Investig Drugs 22(12):1511-7, 2013. PMID: 23978196.
3. Naing A. Overcoming resistance to mTOR inhibition for enhanced strategies in clinical trials. Expert Opin Investig Drugs 22(6):679-685, 2013. PMID: 23631743.

Abstracts

1. Naing A, Callahan M, Costello BA, Curti B, Hall E, Hansen A, Long GV, Joshua AM, Wetmore C, Weickhardt A. A first-in-human phase 1 study of NL-201 in patients with relapsed or refractory cancer. AACR Annual Meeting 2022, 2022. e-Pub 2022.
2. Nelson BE, Roszik J, Janku F, Hong D, Kato S, Naing A, Piha-Paul SA, Fu S, Tsimberidou A, Cabanillas M, Busaidy N, Javle M, Byers L, Heymach J, Meric-Bernstam F. B-Raf V600E harboring non-melanoma cancers treated with Vemurafenib monotherapy and in combination with Everolimus/Sorafenib/Crizotinib/Paclitaxel+ Carboplatin: A pooled analysis of five phase 1/2 studies. AACR Annual Meeting 2022, 2022. e-Pub 2022.
3. Hill JA, White KF, Rausch M, J-K C, Patnaik A, Naing A, Morgensztern D, Mantia CM, Tannir NM, Smith LS, Vowers B, Alika A, Harshman LC, Lee BH. Determination of a recommended Phase 2 dose (RP2D) for SRF388, a first-in-class IL-27-blocking antibody, in patients with advanced solid tumors. AACR Annual Meeting 2022, 2022. e-Pub 2022.
4. Lillie T, O'Hara M, Ottensmeier C, Parkes E, Rosen L, Krige D, Chaney M, Carter J, Evilevitch V, Thomas M, Naing A. A multicenter phase 1a/b study of NG-350A, a tumor-selective anti-CD40-antibody expressing adenoviral vector, and pembrolizumab in patients with metastatic or advanced epithelial tumors (FORTIFY). AACR Annual Meeting 2021, 2022. e-Pub 2022.
5. Champiat S, Marabelle A, Galvao V, LoRusso P, Grell P, Cassier P, Gomez-Roca C, KorakisI, Naing A, Jelinkova LP, Adkins I, Moebius U, Sachse R, Tillmanns S, Bechard D, Kiemle-Kallee J, Garralda E. SOT101, an IL-2/IL-15 Rβγ superagonist, in combination with pembrolizumab in patients with advanced solid tumors: Interim safety and efficacy results from the AURELIO-03 dose escalation trial. AACR Annual Meeting 2022, 2022. e-Pub 2022.
6. Surana R, Rogers JE, Nogueras-Gonzalez GM, Hong DS, Yap TA, Rodon Ahnert J, Naing A, Wolff RA, Smalgo BG, Meric-Bernstam F, Subbiah V, Pant S. Prognostic factors associated with survival in patients with pancreatic cancer treated on early phase immune-checkpoint inhibitor clinical trials. ASCO Gastrointestinal Cancers Symposium, 2022. e-Pub 2022.
7. Marabelle A, Champiat S, Galvao V, Naing A, Janku F, LoRusso P, Grell P, Sachse R, Bechard D, Kiemle-Kallee J, Garralda E. Recommended Phase 2 Dose, Pharmacokinetics, Pharmacodynamics, And Preliminary Efficacy Of The IL-15 Superagonist SO-C101 As Monotherapy In Patients With Advanced/ Metastatic Solid Tumors. SITC Annual Meeting 2021, 2021. e-Pub 2021.
8. Watson G, McKean M, Tolcher A, Victor A, Zhang S, Pierre V, Richter E, Naing A. A First-In-Human Phase I Study Of M6223 (TIGIT INHIBITOR) As Monotherapy Or In Combination With Bintrafusp Alfa In Patients With Metastatic Or Locally Advanced Solid Unresectable Tumors. SITC Annual Meeting 2021, 2021. e-Pub 2021.
9. Kim R, Barve M, Mamdani H, Johnson M, Lee BH, Ferrando-Martinez S, Chaney M, Fan J, Le N, Naing A. Initial Biomarker And Clinical Data Of A Phase 2a Study Of NT-I7, A Long-Acting Interleukin-7, Plus Pembrolizumab: Cohort Of Subjects With Checkpoint Inhibitor-Naïve Advanced Msscolorectal Cancer. SITC Annual Meeting 2021, 2021. e-Pub 2021.
10. Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Correction to: Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: results of a single center, multi arm phase Ib study. Invest New Drugs, 2021. e-Pub 2021. PMID: 34731355.
11. Naing A, Kim R, Barve M, Johnson M, Lee BH, Ferrando-Martinez S, Pant S, Wolff R, Haymaker C, Chaney M, Kim DW, Fan J, Le N, Mamdani H. Preliminary Biomarker And Clinical Ata Of A Phase 2a Study Of NT-I7, A Long-Acting Interleukin-7, Plus Pembrolizumab: Cohort Of Subjects With Checkpoint Inhibitor-Naïve Advanced Pancreatic Cancer. SITC Annual Meeting 2021, 2021. e-Pub 2021.
12. Garralda E, Galvao V, Champiat C, LoRusso P, Grell P, Naing A, Janku F, Sachse R, Bechard D, Kiemle-Kallee J, Marabelle A, Garralda E. Preliminary Efficacy Of The IL-15 Superagonist SO-C101 In Combination With Pembrolizumab In Patients With Advanced/Metastatic Solid Tumors. SITC Annual Meeting 2021, 2021. e-Pub 2021.
13. de Miguel Perez D, Barrón F, Russo A, Lara-Mejía L, Gunasekaran M, Cardona A, Peterson C, Colen R, Naing A, Mack P, Hirsch F, Adamo V, Arrieta O, Rolfo C. Validation Of PD-L1 Dynamic Expression On Extracellular Vesicles As A Predictor Of Response To Immune-Checkpoint Inhibitors And Survival In Non-Small Cell Lung Cancer Patients. SITC Annual Meeting 2021, 2021. e-Pub 2021.
14. Naing A, Callahan M, Costello B, Bifulco C, Hall E, Hansen A, Long G, Joshua A, Shankles B, Ulge U, Weickhardt A. A First-In-Human Phase 1 Study Of NL-201 In Patients With Relapsed Or Refractory Cancer. SITC Annual Meeting 2021, 2021. e-Pub 2021.
15. Burton E, Dumbrava EEI, Peng W, Milton D, Amaria R, Mcquade J, Glitza IC, Hong D, Patel S, Rodon J, Yap TA, Naing A, Piha-Paul SA, Balmes G, Lazar A, Meric-Bernstam F, Hwu P, Davies MA, Tawbi HA. Ph I/II study of PI3K-β inhibitor GSK2636771 (G771) in combination with pembrolizumab (P) in patients (pts) with PTEN loss and melanoma or other advanced solid tumors. ESMO Congress 2021, 2021. e-Pub 2021.
16. Moyers J, Nguyen D, Hong DS, Dumbrava EI, Fu S, Karp D, Naing A, Pant S, Janku F, Piha-Paul S, Rodon J, Subbiah V, Tsimberidou AM, Meric-Bernstam F, Yap T. Adherence to the Food and Drug Administration (FDA) Guidance for the Co-Development of Two or More Investigational New Drugs in Phase 1/2 Cancer Trials. ESMO Congress 2021, 2021. e-Pub 2021.
17. Naing A, Rosen L, Camidge RD, Khalil D, Davies J, Miles D, Patel M, Cockle P, Champion B, Krige D, Lillie T. FORTITUDE phase I study of NG-350A, a novel tumour-selective adenoviral vector expressing an anti-CD40 agonist antibody: Monotherapy dose escalation results. ESMO Congress 2021, 2021. e-Pub 2021.
18. Patnaik A, Morgensztern D, Mantia C, Tannir NM, Harshman LC, Hill J, White K, J-K C, Bowers B, Sciaranghella G, Lee B, Choueiri TK, Smith LS, Naing A. Results of a phase 1 study of SRF388, a first-in-human, first-in-class, high-affinity anti-IL-27 antibody in advanced solid tumors. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
19. Abo-Zahrah R, Karp DD, Adat A, Yap TA, Fu S, Rodon J, Piha-Paul SA, Tsimberidou AM, Naing A, Subbiah V, Dumbrava EE, Overman MJ, Patel SP, Amaria RN, Westin SN, Meric-Bernstam F, Janku F. Patients with advanced solid cancers treated with ERK inhibitors exhibit pseudo-progession in lymphatic nodes. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
20. Rolfo CD, de Miguel Perez D, Russo A, Ak M, Gunasekaran M, Manca P, Peterson CB, Mamindla P, Er ME, Peddagangireddy V, Buemi F, Cooper B, Hester L, R-C H, Cardona AF, Arrieta O, Naing A, Kaushal S, Serrano MJ, Colen RR. Dynamic levels of extracellular vesicle PD-L1 and complementary radiomics for the prediction of the response to immune checkpoint inhibitors in lung cancer patients. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
21. Naing A, Fan J, Lee BH, Basudhar D, Pant S, Chaney MF, Laviada C, Rajan C, Le NT, Barve MA. Safety, pharmacokinetics, pharmacodynamics profiles and preliminary antitumor activity of phase 1b/2a study of NT-I7, a long-acting interleukin-7, plus pembrolizumab in patients with advanced solid tumors: The phase 1b data report. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
22. Patel MR, Naing A, Burris III HA, C-C L, Curigliano G, Thistlethwaite F, Minchom AR, Ascierto PA, De Braud FG, Cecchini M, Hanekom W, Sainson RCA, Wilson RJ, Quaratino S. A phase 1/2 open-label study of KY1044, an anti-ICOS antibody with dual mechanism of action, as single agent and in combination with atezolizumab, in adult patients with advanced malignancies. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
23. Gordon M, Roszik J, Cabanillas ME, MI-N H, Busaidy NL, Sherman SI, Dadu R, Grubbs EG, Elamin YY, Cascone T, Byers LA, Blumenschein GR, Fossella FV, Naing A, Hong DS, Heymach J, Meric-Bernstam F, Subbiah V. Prognostic factors in RET dependent cancers treateded with RET inhibitors in early phase clinical trials. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
24. C-C L, Naing A, Patel MR, Burris III HA, Curigliano G, Thistlethwaite F, Minchom AR, Ascierto PA, De Braud FG, Eder JP, Wake M, Palu CC, Newton AL, Deantonio C, Hanekom W, Sainson RCA, Quaratino S. KY1044 to target the ICOS pathways inducing intratumoral Treg depletion and agonism of effector T cells: Preliminary pharmacodynamic markers from a phase 1/2 multicenter trial. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
25. Coleman N, Naing A, Zhang S, Piha-Paul SA, Tsimberidou AM, Janku F, Rodon J, Pant S, Dumbrava EE, Fu S, Hong DS, Meric-Bernstam F, Subbiah V. Phase I study of mTORC1/2 inhibitor sapanisertib (TAK-228) in combination with metformin in patients (pts) with mTOR/AKT/PI3K pathway alterations and advanced solid malignancies. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
26. Westin SN, Fu S, Tsimberidou AM, Piha-Paul SA, Akhmedzhanov F, Yilmaz B, McQuinn L, Brink AL, Gong J, Leung CH, Lin HY, Hong DS, Pant S, Jazaeri AA, Gershenson DM, Sood AK, Coleman RL, Shah JJ, Meric-Bernstam F, Naing A. Selinexor in combination with weekly paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multiarm phase 1b study. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
27. Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul SA, Subbiah V, Janku F, Naing A, Yap TA, Rodon JA, Ajani JA, Cartwright CC, Naqvi MF, Nogueras-Gonzalez GM, Miller VA, Palmer GA, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT2): Challenges and Opportunities in Conducting an MD Anderson Randomized Study in Precision Oncology. ASCO Annual Meeting 2021, 2021. e-Pub 2021.
28. Alhalabi O, Naing A, Groisberg R, Hahn A, Zhang S, Berkey SC, Tsimberidou AM, Rodon J, Yap TA, Pant S, Shah AY, Zurita-Saavedra A, Tannir N, Meric-Bernstam F, Subbiah V. Phase I study of mTORC1-2 inhibitor sapanisertib (TAK-228) in combination with carboplatin plus paclitaxelin patients with advanced solid malignancies and mTOR pathway alterations. AACR Annual Meeting 2021, 2021. e-Pub 2021.
29. Javle MM, Bridgewater JA, Gbolahan OB, Jungels C, Cho MT, Papadopoulos KP, Thistlethwaite FC, J-L RC, Cheng L, Ioannidis S, Gogov S, Naing A. A phase I/II study of safety and efficacy of the arginase inhibitor INCB001158 plus chemotherapy in patients (Pts) with advanced biliary tract cancers. 2021 ASCO Gastrointestinal Cancers Symposium, 2021. e-Pub 2021.
30. Rovira JJI, Vikram R, Thirumurthi S, Yilmaz B, Lin H, Akhmedzhanov FO, Hong DS, Zarifa A, Tagart M, Meric-Bernstam F, Naing A. Role of CT Scans of Abdomen and Pelvis in Management of Patients with Immunotherapy-induced Colitis. SITC Annual Meeting 2020, 2020. e-Pub 2020.
31. de Miguel Perez D, Russo A, Gunasekaran M, Cardona AF, Lapidus R, Cooper B, Kaushal S, Peterson CB, Colen R, Naing A, Adamo V, Rolfo C. Dynamic change of PD-L1 expression on extracellular vesicles predicts response to immune-checkpoint inhibitors in non-small cell lung cancer patients. SITC Annual Meeting 2020, 2020. e-Pub 2020.
32. Murthy R, Sheth RA, Tam A, Gupta S, Subbiah V, Janku F, Yap TA, Diab A, Naing A, Patel SP, Meric-Bernstam F. Intra-Tumor Immunotherapy Injections utilizing Image guidance in Interventional Radiology: Clinical Trial Experience at a Tertiary care Cancer Center. SITC Annual Meeting 2020, 2020. e-Pub 2020.
33. Naing A, Karp DD, Piha-Paul SA, Haymaker C, Parra ER, Yang F, Pant S, Hong DS, Fu S, Yap TA, Stephen B, Yang Y, Lin H, Leung CH, Daver N, Choi Y, Hajjar J, Wistuba I, Hwu P, Meric-Bernstam F, Rodon Ahnert J. Immune correlates associated with clinical outcomes in patients with advanced malignancies treated with avelumab and OX40 agonist. SITC Annual Meeting 2020, 2020. e-Pub 2020.
34. Gouda MA, Huang HJ, Piha-Paul SA, Call SG, Karp DD, Fu S, Naing A, Subbiah V, Pant S, Tsimberidou AM, Hong DS, Rodon J, Meric-Bernstam F. Circulating Tumor DNA Dynamics Predict Outcomes of Systemic Therapy in Patients with Advanced Cancers. ENA 2020, 2020. e-Pub 2020.
35. Call SG, Huang HJ, Rodon J, Karp DD, Tsimberidou AM, Naing A, Janku F. Targeted next-generation sequencing (NGS) of 105 cancer-related genes in circulating tumor DNA (ctDNA) from patients with advanced cancers treated with immune checkpoint inhibitors (iCPI). AACR Tumor Immunology and Immunotherapy, 2020. e-Pub 2020.
36. Thein KZ, Tsimberidou AM, Piha-Paul SA, Janku F, Karp DD, Fu S, Zarifa A, Gong J, Yap TA, Hong DS, Subbiah V, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced or metastatic solid tumours: Results of an open label, single-center, multi-arm phase Ib study. ESMO Virtual Congress 2020, 2020. e-Pub 2020.
37. Glitza IC, Patel SP, Zarifa A, Leung CH, Lin H, McQuinn L, Gong J, Yilmaz B, Chambers J, Sulovic S, John I, Hennegan T, Fu S, Tsimberidou AM, Janku F, Karp DD, Meric-Bernstam F, Naing A. Phase Ib study to evaluate the safety of selinexor (SEL) in combination with pembrolizumab (PEM) in patients with advanced malignancies- the: The melanoma experience. ESMO Virtual Congress 2020, 2020. e-Pub 2020.
38. Alhalabi O, Hahn AW, Msaouel P, Meric-Bernstam F, Naing A, Piha-Paul SA, Janku F, Pant S, Yap TA, Hong DS, Fu S, Karp DD, Campbell E, Campbell MT, Shah AY, Tannir A, Siefker-Radtke AO, Gao J, Roszik J, Subbiah V. Validation of prognostic scores in patients with metastatic bladder carcinoma (mBC) enrolled in early phase clinical trials. ESMO Virtual Congress 2020, 2020. e-Pub 2020.
39. Al-Zubidi N, Gombos D, Patel N, Whyte A, Razmandi A, Naing A. Ocular Toxicity Profile of Targeted Cancer Therapy at a US Tertiary Cancer Center. American Academy of Opthamology, 2020. e-Pub 2020.
40. Lin CC, Gil-Martin M, Bauer TM, Naing A, Lim DW, Sarantopoulos J, Geva R, Ando Y, Fan L, Choudhury S, Tu P, Quadt C, Santoro A. Phase I study of BLZ945 alone and with spartalizumab (PDR001) in patients (pts) with advanced solid tumors. AACR Annual Meeting 2020, 2020. e-Pub 2020.
41. Naing A, Karp D, Piha-Paul SA, Pant S, Subbiah V, Bodurka DC, Fu S, Jazaeri AA, Kato S, Schmeler K, Nick A, Yang Y, Fechukwu AO, Fessahaye S, Gong J, Stephen B, Johnson AM, Soliman PT, Sood AK, Meric-Berstam F, Lu KH. Temsirolimus in combinaton with metformin in patients with advanced or refractory endometrial cancers. AACR Annual Meeting 2020, 2020. e-Pub 2020.
42. Chae YK, Othus M, Patel SP, Ohr JP, Worden FP, Suga JM, Naing A, Fenton SE, Kang H, Gurung S, McLeod CM, Giles FJ, Chen HX, Sharon E, Mayerson E, Plets M, Ryan CW, Blanke CD, Kurzrock R. A phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: The salivary gland tumor cohort. AACR Annual Meeting 2020, 2020. e-Pub 2020.
43. Wu J, Lin CC, Gil-Martin M, Naing A, Fan L, Yang F, Quinn D, Tu P, Quadt C, Mataraza J. Pharmacodynamic and gene expression profiling of patients treated with BLZ945 + spartalizumab demonstrates on-target peripheral and tumor immune microenvironment modulation. AACR Annual Meeting 2020, 2020. e-Pub 2020.
44. Colen RR, Ahmed S, Elshafeey N, Karp DD, Pant S, Subbiah V, Piha-Paul SA, Hong DS, Yap TA, Fu S, Tsimberidou AM, Stephen B, Gong J, Ahnert JR, Naing A. Radiomics to predict response to pembrolizumab in patients with advanced rare cancers. ASCO SITC 2020, 2020. e-Pub 2020.
45. Hahn AW, Alhalabi O, Meric-Bernstam F, Naing A, Jonasch E, Msaouel P, Piha-Paul SA, Hong DS, Pant S, Yap TA, Campbell E, Le H, Tannir NM, Roszik J, Subbiah V. Phase I clinical trials as a therapeutic option for patients with metastatic renal cell carcinoma (mRCC). ASCO Annual Meeting 2020, 2020. e-Pub 2020.
46. Subbiah IM, Buzdar A, Dumbrava E, Fu S, Janku F, Karp DD, Naing A, Pant S, Rodon J, Tsimberidou AM, Yap TA, Subbiah V, Meric-Bernstam F, Hong DS. Investigating the disparate enrollment of older adults on phase I clinical trials: evolving participation patterns of patients 65 years and older w advanced cancer on phase I trials. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
47. Call SG, Huang HJ, Rodon J, Karp DD, Tsimberidou AM, Naing A, Janku F. Targeted next-generation sequencing (NGS) of 105 cancer-related genes in circulating tumor DNA (ctDNA) from patients with advanced cancers treated with immune checkpoint inhibitors (iCPI). ASCO Annual Meeting 2020, 2020. e-Pub 2020.
48. Soto F, Zhong L, Shannon VR, Wilson N, Zarifa A, Akhmedzhanov FO, Heymach J, Arain MH, Lewis J, Rinsurongkawong W, Lee JJ, Zhang J, Swisher S, Mendoza TR, Naing A, Sheshadri A, Altan M. Incidence and risk factors for pneumonitis associated with immune checkpoint inhibitors in advanced-stage non-small cell lung cancer: A single center experience. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
49. Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Ahnert JR, Meric-Bernstam F, Shih YT, Hong DS. Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
50. Murthy R, Sheth R, Subbiah V, Janku F, Naing A, Rodon J, Yap TA, Diab A, Patel SP, Tam A, Gupta S, Meric-Bernstam F. Intratumor immunotherapy utilizing real time radiological image guidance: Early experience from a tertiary cancer center. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
51. Lyman S, Naing A, Zein IA, Howng B, Winter MB, Vasiljeva O, Garner W, Zheng B, Stroh M, Kavanaugh WM, Desnoyers LR. Evidence of intratumoral localization, activation, and immunomodulatory effect of CX-072, a probody therapeutic targeting PD-L1, in a phase I/II trial. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
52. Thistlethwaite F, Naing A, Gil-Martin M, LoRusso P, Randhawa M, Eskens F, Sanborn RE, Uboha NV, Cho DC, Spira AI, Bondarenko I, Plummer ER, Garcia-Corbacho J, Victoria I, Lavernia J, Melero I, De Vries E, Garner W, Arkenau H, Bendell JC. Analysis of patients with advanced solid tumors receiving long-term treatment with CX-072, a PD-L1 probody therapeutic, as a single agent or in combination with ipilimumab. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
53. Gouda MA, Huang HJ, Piha-Paul SA, Call SG, Karp DD, Fu S, Naing A, Subbiah V, Pant S, Tsimberidou AM, Hong DS, Rodon J, Meric-Bernstam F, Janku F. Genomically Informed Longitudinal Monitoring of Circulating Tumor DNA (ctDNA) Predicts Outcomes of Cancer Therapy. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
54. Alhalabi O, Hahn AW, Meric-Bernstam F, Naing A, Piha-Paul SA, Janku F, Pant S, Yap TA, Hong DS, Fu S, Campbell E, Le H, Shah AY, Campbell MT, Tannir NM, Siefker-Radtke AO, Gao J, Roszik J, Subbiah V. Outcomes and the impact of genomic characteristics on patients with metastatic urothelial carcinoma enrolled in early phase trials. ASCO Annual Meeting 2020, 2020. e-Pub 2020.
55. Frumovitz M, Westin S, Salvo G, Yap T, Rodon J, Karp D, Abonofal A, Jazaeri A, Naing A. Phase II Study of Pembrolizumab for High-Grade Neuroendocrine Tumors of the Cervix and Vulva. SGO Annual Meeting on Women's Cancer 2020, 2020. e-Pub 2020.
56. Ott PA, Govindan R, Naing A, Friedlander TW, Margolin K, Lin JJ, Bhardwaj N, Hellman MD, Awah MM, Wanamaker A, Cleary LD, Rooney MS, Cherer J, Bushway ME, Moles M, Khondker Z, Gaynor RB, Srinivasan L, Chi A, Greshock J, Hu-Lieskovan S. Disease-related biomarkers are associated with extended progression free survival after treatment with NEO-PV-01 in combination with anti-PD1 in patients with metastatic cancers. SITC Annual Meeting 2019, 2019. e-Pub 2019.
57. Mendoza T, Sheshadri A, Hess K, Altan M, George G, Stephen B, Rodriguez E, Yap TA, Janku F, Fu S, Subbiah V, Piha-Paul SA, Rodon-Ahnert J, Karp DD, Cleeland C, Hong D, Meric-Bernstam F, Naing A. Symptom burden of patients with metastatic solid tumors receiving Pembrolizumab in an early phase trial. International Society for Quality of Life (ISOQOL) 26th Annual Conference, 2019. e-Pub 2019.
58. Naing A, Meric-Bernstam F, Karp D, Rodon JA, Piha-Paul SA, Subbiah V, Hong DS, Pant S, Fu S, Janku F, Yap TA, Tsimberidou AM, Ileana Dumbrava EE, Colen RR, Hess KR, Campbell MT, Tu SM, Jimenez C, Habra MA, Varadhachary GR. Pembrolizumab in advanced rare cancers. ESMO Annual Congress 2019, 2019. e-Pub 2019.
59. Mendoza T, Sheshadri A, Hess K, Altan M, Stephen B, Cleeland C, Hong D, Naing A. Evaluating the psychometric properties of the immunotherapy module of the MD Anderson Symptom Inventory (MDASI-Immunotherapy). JSM Meeting 2019, 2019. e-Pub 2019.
60. Naing A, Thistlethwaite FC, Spira AI, Garcia-Corbacho J, Randhawa M, Eskens F, O’Neil B, Lavernia J, Uboha NV, Hamid O, El-Khoueiry AB, Benson BA, Garner W, Huels VJ, Arkenau HT, LoRusso P. CX-072, a PD-L1 probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
61. Yap TA, Ahnert JR, Piha-Paul SA, Fu S, Janku J, Karp DD, Naing A, Dumbrava EEI, Pant S, Subbiah V, Tsimberidou AM, Hong DS, Rose KM, Xu Q, Vellano CP, Mahendra M, Jones P, Di Francesco ME, Marszalek JR, Meric-Bernstam F. Phase I trial of IACS-010759 (IACS), a potent, selective inhibitor of complex I of the mitochondrial electron transport chain, in patients (pt) with advanced solid tumors. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
62. Sen S, Pestana R, Hess KR, Hong DS, Janku F, Naing A, Falchook GS, Conley AP, Patel S, Meric-Bernstam F, Subbiah V. Precision oncology in sarcoma drug development: Impact of genomic matching on response, clinical benefit, and survival in sarcoma patients on phase I trials. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
63. Khan A, Zhang H, Chen C, Morgan J, Zarifa A, Shahid M, Song J, Naing A, Lopez-Mattei J, Durand JB, Kim PY, Iliescu C, Palaskas N. Impact of pericardial effusion for patients receiving immune checkpoint inhibitors. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
64. Sen S, Hess KR, Hong DS, Falchook GS, Pestana R, Janku F, Naing A, Benjamin RS, Patel S, Meric-Bernstam F, Subbiah V. Survival and signals of response in advanced sarcoma patients enrolled on phase 1 trials in the era of precision oncology and novel immunotherapies. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
65. Naing A, Dumbrava EEI, Murthy R, Meric-Bernstam F, Fox A, Krige D, Carter J, Champion B, Cockle P, Koetz B, McElwaine-Johnn H. A multicentre, open label, first-in-human study of an oncoloytic viral vector expressing an agonistic anti-CD40 antibody (NG-350A) in patients with epithelial tumors (FORTITUDE). ASCO Annual Meeting 2019, 2019. e-Pub 2019.
66. Huey R, George G, Phillips P, White R, Fu S, Janku F, Karp DD, Naing A, Piha-Paul SA, Subbiah V, Tsimberidou AM, Pant S, Yap TA, Ahnert JR, Meric-Bernstam F, Shih YT, Hong DS. Out of pocket costs and financial toxicity experienced by patients in early phase clinical trials. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
67. Pestana RC, Subbiah IM, Hess KR, Huang L, Liu S, Beltran K, Harrison H, Bryant A, Eshon J, Yap TA, Pant S, Naing A, Hong DS, Meric-Bernstam F, Subbiah V. Re-evaluating elegibility criteria: Analysis of factors leading to nonparticipation and outcomes of patients (pt) with advanced cancer who signed consent but were not treated in early-phase immunotherapy (IO) trials. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
68. Reilley M, Tsimberidou AM, Piha-Paul SA, Yap TA, Fu S, Naing A, Rodon J, Nguyen LM, Ager C, Meng M, Jayaprakash P, Schmidt M, Baumann M, Meric-Bernstam F, Curran MA, Hong DS. Phase 1 trial of TLR9 agonist lefitolimod in combination with CTLA-4 checkpoint inhibitor ipilimumab in advanced tumors. ASCO Annual Meeting 2019, 2019. e-Pub 2019.
69. Papadopoulos K, Eder P, Piha-Paul SA, Gimmi C, Hussey E, Zhang S, Li L, Habermehl C, Naing A. First-in-human phase I study of M4112, the first dual inhibitor of indoleamine 2,3-dioxygenase-1 and tryptophan 2,3-dioxygenase 2, in patients with advanced solid malignancies. AACR Annual Meeting 2019, 2019. e-Pub 2019.
70. Kurnit KC, Meric-Bernstam F, Hess K, Coleman RL, Bhosale P, Savelieva K, Janku F, Hong D, Naing A, Pant S, Rodon J, Yap TA, Sood AK, Soliman PT, Gershenson DM, Mills GB, Westin SN. Phase I dose escalation of olaparib (PARP inhibitor) and selumetinib (MEK inhibitor) combination in solid tumors with Ras pathway alterations. AACR Annual Meeting 2019, 2019. e-Pub 2019.
71. Shen L, Chen J, Johnston SA, Hong D, Gao J, Naing A. A simple blood base test for predicting clinical benefit of cancer immunotherapy. AACR Annual Meeting 2019, 2019. e-Pub 2019.
72. Hu-Lieskovan S, Ott PA, Naing A, Besada RH, Gates SJ, Kohler VR, Curran RR, Bushway ME, Scherer J, Balogh KN, Sciuto TE, Ting YS, Rooney MS, Harjanto D, Huang Z, Huang Y, Ware Y, Lamb A, Cleary LD, Moles MA, Gaynor RB, Goldstein MJ, Brail LH, Greshock J, Srinivasan L. The personalized vaccine, NEO-PV-01 with anti-PD1, induces neoantigen-specific de novo immune responses in patients with advanced metastatic melanoma: Association with clinical outcomes. AACR Annual Meeting 2019, 2019. e-Pub 2019.
73. Curigliano G, Gelderblom H, Mach N, Doi T, Tai WD, Forde P, Sarantopoulos J, Bedard PL, Lin C, Hodi S, Wilgenhof S, Santoro A, Sabatos-Peyton C, Longmire T, Kitty W, Nikolopoulos P, Manenti L, Naing A. Phase I/II study of MBG453 ± spartalizumab (PDR001) in patients with advanced malignancies. AACR Annual Meeting 2019, 2019. e-Pub 2019.
74. Dumbrava EI, Huang HJ, Stuckett A, Madwani K, Adat A, Hong DS, Piha-Paul S, Subbiah V, Karp D, Fu S, Naing A, Tsimberidou AM, Moulder S, Koenig K, Barcenas CH, Kee B, Dogelman D, Kopetz S, Meric-Bernstam F, Janku F. PIK3CA mutations in plasma cell-free DNA predict survival and treatment outcomes in patients with advanced cancers. AACR Annual Meeting 2019, 2019. e-Pub 2019.
75. Habra MA, Campbell M, Jimenez C, Karp D, Hong D, Subbiah V, Pant S, Ahnert JR, Alshawa A, Painter J, Khan S, Rejon M, Stephen B, Tapia C, Mendoza T, Colen R, Hess K, Meric-Bernstam F, Naing A. Efficacy of pembrolizumab in patients with adrenocortical carcinoma. EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, 2018. e-Pub 2018.
76. Creasy C, Haymaker C, Forget MA, Singh G, Tapia C, Bernatchez C, Painter J, Meric-Bernstam F, Naing A. Exposure to anti-PD-1 cases Functional Differences in Tumor-Infiltrating Lymphocytes in Solid Tumors. SITC 2018 Annual Meeting, 2018. e-Pub 2018.
77. Ahmed S, Elshafeey N, Huang HJ, Madwani K, Fu S, Tsimberidou AM, Piha-Paul SA, Naing A, Hong D, Karp DD, Cabrilo G, Kopetz S, Subbiah V, Kee BK, Eng C, Morris VK, Meric-Bernstam F, Colen R, Janku F. Circulating tumor cell-free DNA correlates with the total volume and survival in patients with advanced cancers. EROTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, 2018. e-Pub 2018.
78. Pant S, Subbiah V, Janku F, Hong D, Karp D, Piha-Paul S, Tsimberidou AM, Naing A, Fu S, Savage RE, Chai F, Yu Y, Tith K, Alfattal R, Schwartz B, Meric-Bernstam F, Eathiraj S, Yap T. A phase I does escalation study of ARQ 751 in adult patients with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations. EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, 2018. e-Pub 2018.
79. Ferrarotto R, Glisson B, Blumenschein G, Hong D, Piha-Paul S, Jain D, Alshawa A, Painter J, Hess K, Colen R, Bernatchez C, Lu C, Stephen B, Tapia C, Mendoza T, Meric-Bernstam F, Naing A. Efficacy of pembrolizumab in patients with cutaneous squamous cell carcinoma. EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, 2018. e-Pub 2018.
80. Naing A, Autio KA, Falchook GS, Meric-Bernstam F, Litton JK, Ibrahim NK, Hung A, Oft M, Leveque J, Patel MR. Responses and durability of clinical benefit in triple negative breast cancer patients treated with Pegilodecakin monotherapy or in combination with platinum plus taxane-based chemotherapy, 2018. e-Pub 2018.
81. Naing A, Autio KA, Falchook GS, Meric-Bernstam F, Litton JK, Ibrahim NK, Hung A, Oft M, Leveque J, Patel MR. Durability of clinical benefit in metastatic epithelial ovarian cancer patients treated with Pegilodecakin monotherapy or in combination with platinmum plus taxane-based chemotherapy. 43rd ESMO Cancer Congress 2018, 2018. e-Pub 2018.
82. Garon, EB, Wong DJ, Schneider JG, Aljumaily R, Korn WM, Patel MR, Autio KA, Papadopolous KP, Naing A, Gabrail N, Munster PN, Goldman J, Hung A, Oft M, Leveque J, Spigel DR. Responses and durability of clinical benefit in non-small cell lung cancer treated with Pegilodecakin in combination with anti-PD-1 inhibitors. 43rd ESMO Cancer Congress 2018, 2018. e-Pub 2018.
83. Rischin D, Gil-Martin M, Gonzalez-Martin A, Brana I, Hou JY, Cho D, Falchook G, Formenti S, Jabbour S, Moore K, Naing A, Papdopoulos KP, Baranda J, Weise A, Fury M, Feng M, Li J, Lowy I, Mathias M. Cemiplimab, a human PD-1 monoclonal antibody, in patients with recurrent or metastatic cervical cancer: Interim data from phase 1 cohorts. ESMO 2018 Annual Meeting, 2018. e-Pub 2018.
84. Boni V, Garcia-Corbacho J, Ott PA, Cho DC, Autio KA, Uboha N, Spira AI, Humphrey R, Will M, Naing A, Thistlewaite F, de Vries EGE, Arkenau H. Preliminary results of PROCLAIM-CX-072: The first-in-human, dose finding trial PD-L1 probody therapeutic CX-072 as monotherapy in patients (pts) with advanced solid tumors. 43rd ESMO Cancer Congress 2018, 2018. e-Pub 2018.
85. Denlinger CS, Infante J, Aljumaily R, Naing A, Chintakuntlawar A, Rizvi N, Ross H, Gordon M, Kumar R, Ma M, Yan L, Vicini P, Standifer N, Cann J, Perera A, Durham N, Krishnan S, Balmanoukian AS. A phase 1 study of MEDI1873, a novel GITR agonist, in advanced solid tumors. ESMO 2018 Annual Meeting, 2018. e-Pub 2018.
86. Ott PA, Govindan R, Naing A, Friedlander TW, Margolin K, Lin JJ, Bhardwaj N, Hellman MD, Srinivasan L, Greshock J, Moles M, Gaynor RB, Goldstein MJ, Hu-Lieskovan S. A personal meoantigen vaccine, NEO-PV-1, with anti-PD-1 induces broad de novo anti-tumor immunity in patients with metastatic melanoma, NSCLC, and bladder cancer. 43rd ESMO Cancer Congress 2018, 2018. e-Pub 2018.
87. Hecht JR, Naing A, Flachook GS, Patel MR, Aljumaily R, Wong DJ, Autio KA, Wanberg ZA, Javle M, Bendell J, Pant S, Hung A, Oft M, Leveque J, Papdopoulos KP. Responses and durability of clinical benefit in pancreatic ductal adenocarcinoma (PDAC) patients treated with Pegilodecakin (AM0010) in combination with 5-FU/LV and oxaliplatin (FOLFOX). 43rd ESMO Cancer Congress 2018, 2018. e-Pub 2018.
88. Garon EB, Schneider JG, Wong DJL, Aljumaily R, Korn WM, Infante JR, Patel MR, Autio KA, Papadopoulos KP, Naing A, Gabrail NY, Munster PN, Goldman JW, Hung A, Van Vlasselaer P, Leveque J, Oft M, Spigel DR. Responses and durability in NSCL treated with Pegilodecakin and anti-PD-1. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
89. Piha-Paul SA, Fu S, Hong DS, Janku F, Karp DD, Naing A, Pant S, Anhert JR, Subbiah V, Tsimberidou AM, Yap TA, Meric-Bernstam F. Phase I study of the pan-HER inhibitor neratinib given in combination with everolimus, palbociclib or trametinib in advanced cancer subjects with EGFR mutation.amplification, HER2 mutation/amplification or HER3/4 mutation. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
90. Kheder E, Hess KR, Xing Y, Cortez MA, Subbiah V, Janku F, Fu S, Naing A, Karp DD, Piha-Paul SA, Pay TA, Pant S, Ahnert JR, Tawbi HA, Welsh JW, Meric-Bernstam F, Hong DS. TP53 mutations and programmed cell death ligand-1 expression in solid tumors: Associations with clinical factors and outcomes. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
91. Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Naing A, Fu S, Piha-Paul SA, janku F, Cartwright C, Broaddus R, Nogueras-Gonzalez GM, Hwu P, Kurzrock R. Precision medicine: Clinical outcomes including long-term survival according to the pathway targeted and treatment period- The IMPACT study. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
92. Tannir, NM, Naing A, Infante JR, Papadopoulos KP, Wong DJL, Korn M, Alijumaily R, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Van Vlasselaer P, Leveque J, Oft M. Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC). ASCO Annual Meeting 2018, 2018. e-Pub 2018.
93. Sen S, Hess KR, Hong DS, Naing A, Huang L, Meric-Bernstam F, Subbiah V. Impact of immune checkpoint inhibitor does on toxicity, response rate and survival: A pooled analysis of dose escalation phase 1 trials. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
94. Fountzilas E, Krishnan E, Janku F, Fu S, Karp DD, Naing A, Subbiah V, Hong DS, Piha-Paul SA, Vining DJ, Tsimberidou AM. A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without systemic bevacizumab, for patients with advanced cancer and liver involvement. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
95. Groisberg R, Hess KR, Hong DS, Heymach J, Naing A, Piha-Paul SA, Janku F, Javle MM, Hu MI, Conley AP, Meric-Bernstam F, Subbiah V. Outcomes of patients with gene fusion driven cancers treated on early phase clinical trials. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
96. Hecht JR, Naing A, Falchook GS, Patel MR, Inante JR, Aljumaily R, Wong DJ, Autio KA, Wainberg ZA, Javle MM, Bendell JC, Pant S, Hung A, Van Vlasselaer P, Oft M, Papadopoulos KP. Overall survival of PEGylated human IL-10 (AM0010) with 5-FU/LV and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC). ASCO Annual Meeting 2018, 2018. e-Pub 2018.
97. Calvo A, Joensuu H, Sebastian M, Naing A, Bang Y, Martin M, Roda D, Hodi FS, Veloso A, Mataraza J, Baneyx G, Guerreiro N, Liao S, Rabault B, Fjaellskog M, Cervantes A. Phase Ib/II study of lacnotuzumab (MCS110) combined with spartalizumab (PDR001) in patients (pts) with advanced tumors. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
98. Autio KA, Arkenau HT, O’Neil BH, Bendell JC, El-Khoueiry A, Strauss J, Weise A, Uboha NU, Rizvi NA, Zheng B, Desnoyers LStroh M, Carman L, Humphrey RW, Will M, Boni V, Spira AI, Naing A. Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 probody therapeutic CX-072 as monotherapy in patients (pts) with advanced solid tumors. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
99. George G, Mendoza TR, Iwuanyanwu EC, Shi Q, Piha-Paul SA, Williams LA, Karp DD, Naing A, Janku F, Bokhari RH, Wang XS, Hong DS, Cleeland CS. Longitudinal patient-reported symptom severity and symptom interference with acitivity-related and mood-related functioning and survival in patients with advanced cancer on early-phase clinical trials of immunotherapeutic or targeted agents. ASCO Annual Meeting 2018, 2018. e-Pub 2018.
100. Ott PA, Govindan R, Naing A, Friedlander TW, Margolin K, Lin JJ, Bhardwaj N, Hellmann MD, Srinivasan L, Greshock J, Moles M, Gaynor RB, Goldstein MJ, Hu-Lieskovan S. A personal neoantigen vaccine, NEO-PV-01, with anti-PD1 induces broad de novo anti-tumor immunity in patients with metastatic melanoma, NSCLC, and bladder cancer. AACR Annual Meeting 2018, 2018. e-Pub 2018.
101. Balar AV, Mahipal A, Grande E, Villalobos VM, Salas S, Kang TW, Kim SH, Powles T, Tsai F, Naing A, Razak A, Loriot Y, Lee JY, Shin SJ, Morales-Barrera R, Angra N, Xiao F, Abdullah S, Van der Heijden MS. Durvalumab + tremelimumab in patients with metastatic urothelial cancer. AACR Annual Meeting 2018, 2018. e-Pub 2018.
102. Pant S, Subbiah V, Rodon J, Janku F, Hong D, Karp D, Piha-Paul S, Tsimberidou AM, Naing A, Fu S, Savage RE, Chai F, Yu Y, Schwartz B, Meric-Bernstam F, Yap T. Results of a phase I dose escalation study of ARQ 751 in adult subjects with advanced solid tumors with AKT1, 2, 3 genetic alterations, activating PI3K mutations, PTEN-null, or other known actionable PTEN mutations. AACR Annual Meeting 2018, 2018. e-Pub 2018.
103. Hong DS, Parikh A, Shapiro G, Varga A, Naing A, Meric-Bernstam F, Reyderman L, Bao X, Binder TA, Ren M, Siu A, Xu L, Liu M, Dayal S, Bhagawati-Prasad V, Tchakov I, Owa T, Ooi C, Marabelle A. Phase I study of E7046, a novel PGE2 receptor type 4 inhibitor in patients with advanced solid tumors: clinical results and effects on myeloid- and T-lymphoid cell-mediated immunosuppression. ASCO-SITC Clinical Immuno-Oncology Symposium, 2018. e-Pub 2018.
104. Kim S, Shannon V, Sheshadri A, Kantarjian HM, Garcia-Manero G, Im J, Ravandi F, Naing A, Futreal A, Daver NG. TH1/17 hybrid CD4+ cells inbronchial alveolar lavage fluid from leukemia patients with checkpoint inhibitor-induced pneumonitis. ASCO-SITC Clinical Immuno-Oncology Symposium, 2018. e-Pub 2018.
105. Alshawa A, Fujii T, Sbeih HA, Blechacz B, Bilen MA, Hess KR, Suarez-Almazor ME, Hong DS, Tsimberiduo AM, Gong J, Stephen B, Subbiah V, Piha-Paul SA, Fu S, Mendoza TR, Thirumurthi S, Meric-Bernstam F, Naing A, Miller E. Hepatotoxicity in advanced cancer patients receiving immune-based cancer treatment. ASCO-SITC Clinical Immuno Oncology Symposium, 2018. e-Pub 2018.
106. Naing A, Ott PA, Gates SJ, Martinez JG, Curran RR, Kohler VL, Bushway ME, Scherer J, Barthelme D, Dong JZ, Lamb A, Cleary LD, Moles M, Greshock J, Gaynor RB, Goldstein MJ, Srinivasan L. Comprehensive immune and molecular analysis of two metastatic melanoma patients treated with a personal neoantigen vaccine, NEO-PV-01, in combination with anti-PD1: A case study. AACR 2018 Annual Meeting, 2018. e-Pub 2018.
107. Lyman SK, Gordon J, DuPage A, Pramanik P, Howng B, Zein IA, Winter MB, Popova IK, Vasiljeva O, Jones J, Wong K, Singson V, Richardson J, Zheng B, Stroh M, Carman L, Huels V, Autio K, Boni V, Cho D, Garcia-Corbacho J, Ruiz IV, Hamid O, Uboha N, de Vries E, El-Khoueiry A, Spira A, Sanborn RE, Thistlethwaite F, Arkenau HT, Bendell J, Ott PA, Rizvi N, Will M, Kavanaugh WM, Naing A, Desnoyers LR. Preliminary evidence of intratumoral activation and immunomodulatory effect of CX-072, a probody therapeutic antibody prodrug targeting PD-L1, in a phase 1/ 2 trial. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
108. Hu-Lieskovan S, Govindan R, Naing A, Friedlander T, Margolin KA, Lin JJ, Bhardwaj N, Hellmann M, Srinivasan L, Greshock J, Moles M, Gaynor RB, Goldstein MJ, Ott PA. The personal vaccine, NEO-PV-01 with anti-PD1, induces neoantigen-specific de novo tumor-related immunity in patients with advanced cancer. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
109. Tapia C, Xu M, Ouyang F, Alshawa A, Hajjar J, Castillo L, Stephen B, Hess K, Chowdhuri S, Singh G, Le H, Murthy R, Naing A. Tumor burden and lymphocytic infiltrate in baseline and on-treatment biopsies and its associations with response to Pembrolizumab in patients with rare tumors. United States and Canadian Academy of Pathology Annual Meeting, 2018. e-Pub 2018.
110. Naing A, Infante JR, Papadopoulos KP, Chan I, Shen C, Ratti N, Rojo B, Autio K, Wong DJ, Patel MR, Ott PA, Falchook GS, Pant S, Hung A, Mumm JB, Adamow M, McCauley S, Wong P, Van Vlasselaer P, Leveque J, Garon EB, Tannir NM, Oft M. Systemic activation and polyclonal expansion of CD8 T cells in cancer patients on Pegilodecakin alone or in combination with anti-PD-1. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
111. Durham NM, Standifer N, Cann J, Morehouse CA, Yan L, Kovacina K, Liu X, Li J, Wu Y, Steicher K, Vicini P, Perera A, Kumar R, Aljumaily R, Naing A, Chintakuntlawar A, Rizvi NA, Ross H, Gordon MS, Infante J, Denlinger C, Balmanoukian A. Pharmacodynamic activity of MEDI1873, a Glucocorticoid-induced tumor necrosis factor family-related protein (GITR) agonist molecule, administered intravenously to patients with advanced solid tumors. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
112. Hu-Lieskovan S, Ott PA, Naing A, Besada RH, Gates SJ, Kohler VR, Curran RR, Bushway ME, Scherer J, Balogh KN, Sciuto TE, Ting YS, Rooney MS, Harjanto D, Huang Z, Huang Y, Ware Y, Lamb A, Cleary LD, Moles MA, Gaynor RB, Goldstein MJ, Brail LH, Greshock J, Srinivasan L. Ther personalized vaccine, NEO-PV-01 with anti-PD1, induces neoantigen-specific de novo immune responses in patients with advanced metastatic melanoma: Association with clinical outcomes. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
113. Reilley MJ, Ager C, Meng M, Tsimberidou AM, Piha-Paul SA, Yap TA, Fu S, Naing A, Rodon J, Nguyen L, Bhosale P, Schmidt M, Baumann M, Meric-Bernstam F, Curran MA, Hong D. Combination of subcutaneously administered TLR9 agonist lefitolimod with CTLA-4 checkpoint inhibitor ipilimumab- a phase I trial in patients with advanced solid tumors. SITC 33rd Annual Meeting, 2018. e-Pub 2018.
114. Salas C, Lopez G, Cadiz F, Barriga C, Gonzalez P, Acevedo S, Raimilla P, Pincheira P, Naing A, Quiroga M. Use of complementary and integrative medicine therapies in Chilean patients with breast cancer. Experience of a private center: Prevalence and characteristics of patients. San Antonio Breast Cancer Symposium, 2018. e-Pub 2018.
115. Gong J, Coleman RL, Naing A, Lopex-Berestein G, Fu S, Tsimberidou AM, Pant S, Sood AK. EphA2 Gene Targeting using Neutral Liposomal Small Interfereing RNA (EPHARNA) Delivery: A Phase I Clinical Trial. 2017 CPRIT Innovations in Cancer Prevention and Research Conference, 2017. e-Pub 2017.
116. Piha-Paul SA, Xiong WW, Moss T, Mostorino RM, Sedelmeier S, Hess K, Fu S, Hong DS, Janku F, Karp D, Naing A, Pant S, Rodon J, Subbiah V, Tsimberidou AM, Yap T, Javle M, Tapia C, Shaw KR, Eterovic K, Mills GB, Meric-Bernstam F. Phase II study of the PARP inhibitor talazoparib in advanced cancer patients with somatic alterations in BRCA1/2, mutations/deletions in PTEN or PTEN loss, aberrations in other BRCA pathway genes, and germline mutations in BRCA1/2 (not breast or ovarian cancer). AACR-NCI-EORTC, 2017. e-Pub 2017.
117. Tito M, Goldy G, Loretta W, Qiuling S, Aung N, David H, Charles C. Feasibility and added value of multiple baseline symptom assessments in early-phase clinical trials. 24th Annual International Society for Quality of Life (ISOQOL), 2017. e-Pub 2017.
118. Hecht JR, Falchook GS, Patel MR, Aljumaily R, Infante JR, Naing A, Wong DJL, Autio KA, Ratti N, Wainberg ZA, Bendell JC, Pant S, Brown GL, Van Vlasselaer P, Oft M, Papadopoulos KP. Efficacy, safety, and immune activation with pegylated human IL-10 (AM0010) plus FOLFOX in metastatic pancreatic adenocarcinoma (PDAC). 2017 ASCO Annual Meeting, 2017. e-Pub 2017.
119. Naing A, Leong S, Pishvaian MJ, Razak A, Mahipal A, Berlin JD, Cho DC, Senapedis W, Shacham S, Kauffman MG, Ellis J, Meade J, Baloglu E. A First in Human Phase 1 Study of KPT-9274, a First in Class Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or NHL. European Society of Medical Oncology 2017 Annual Meeting, 2017. e-Pub 2017.
120. Xu M, Ouyang F, Alshawa A, Hajjar J, Castillo L, Le H, Murthy R, Naing A, Tapia C. No tumor or very small tumor burden in on-treatment biopsies is significantly associated with response to Pembrolizumab. AACR Special Conference on Tumor Immunology and Immunotherapy, 2017. e-Pub 2017.
121. Infante JR, Papadopoulos KP, Naing A, Autio KA, Ott, PA, Wong DJ, Bendell JC, Bauer, TM, Pant S, Ratti NP, McCauley S, Hung A, Vlasselaer PV, Brown GL, Oft M. PEGylated human IL‐10 (AM0010) monotherapy in refractory metastatic colorectal cancer. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
122. Naing A, Wong DJ, Infante JR, Papadopoulos K, Aljumaily R, Korn WM, Schneider JG, Patel M, Autio KA, Falckook GS, Gabrail NY, Rojo B, Ratti N, McCauley S, Hung A, Vlasselaer PV, Brown GL, Garon EB, Tannir NM, Oft M. . Immune and Tumor Responses to Human IL-10 (AM0010, Pegilodecakin) alone or in combination with immune checkpoint blockade. Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting, 2017. e-Pub 2017.
123. Ferrarotto R, Glisson B, Blumenschein G, Hong D, Piha‐Paul S, Jain D, Alshawa A, Painter J, Hess K, Colen R, Bernatchez C, Lu C, Stephen B, Tapia C, Mendoza T, Meric‐Bernstam F, Naing A. Efficacy of pembrolizumab in patients with cutaneous squamous cell carcinoma. Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting, 2017. e-Pub 2017.
124. Hecht JR, Falchook GS, Patel M, Aljumaily R, Infante JR, Naing A, Wong DJ, Autio KA, Ratti N, Wainberg ZA, Bendell JC, Pant S, Hung A, Vlasselaer PV, Brown GL, Oft M, Papadopoulos. Overall survival and immunologic responses in metastatic pancreatic adenocarcinoma (PDAC) on PEGylated human IL-10 (AM0010) with 5-FU/LV and oxaliplatin (FOLFOX). ESMO 2017 Congress, 2017. e-Pub 2017.
125. Spira AI, Middleton MR, Naing A, Autio KA, Nemunaitis JJ, Bendell JC, Gordon M, Humphrey RW, Wong C, Rizvi NA. PROCLAIM-001: A first-in-human trial to assess tolerability of the protease-activatable anti-PD-L1 Probody CX-072 in solid tumors and lymphomas. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
126. Tsimberidou AM, Hong DS, Cartwright C, Wheler JJ, Falchook GS, Naing A, Fu S, Piha-Paul SA, Janku F, Hwu P, Kee BK, Kies MS, Broaddus R, Mendelsohn J, Hess KR, Kurzrock R. Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT): An MD Anderson precision medicine study. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
127. Torres HA, Economides MP, Kyvernitakis A, Mahale P, Hosry J, Naing A, Turturro F, Kaseb AO, Raad II, Granwehr BP. Sofosbuvir-based therapy in patients with chronic hepatitis C virus infection and malignancies: A prospective study of 143 patients. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
128. Naing A, Lopez-Berestein G, Fu S, Tsimberidou AM, Pant S, Piha-Paul SA, Janku F, Hong DS, Sulovic S, Meng X, Jazaeri AA, Ng CS, Karp DD, Subbiah V, Meric-Bernstam F, Mitra R, Wu S, Sood A, and Coleman RL. EphA2 gene targeting using neutral liposomal small interfering RNA (EPHARNA) delivery: A phase I clinical trial. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
129. Naing A, Infante JR, Hecht JR, Papadopoulos KP, Wong DJL, Autio KA, Falchook GS, Patel MR, Ott PA, Patnaik A, Bendell JC, Vlasselaer PV, Hong DS, Tannir NM, Oft M. Phase I study with pegylated human IL-10 (AM0010) alone or in combination with anti-PD-1 or FOLFOX-immune biomarker update. 2017 ASCO-SITC Clinical Immuno-Oncology Symposium, 2017. e-Pub 2017.
130. Wong DJ, Schneider JG, Aljumaily R, Korn WM, Infante JR, Patel M, Autio KA, Papadopoulos KP, Naing A, Gabrail NY, Munster PN, Goldman J, Ratti N, Vlasselaer PV, Brown GL, Hung A, Oft M< Garon EB. Efficacy, safety, and immune activation with PEGylated human IL‐10 (AM0010) in combination with an anti‐PD1 in advanced NSCLC. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
131. Hecht JR, Naing A, Falchook GS, Patel MR, Infante JR, Aljumaily R, Wong DJL, Autio KA, Wainberg ZA, Javle MM, Bendell JC, Pant S, Van Vlasselaer P, Brown GL, Oft M, Papadopoulos KP. Phase 1b study with PEGylated human IL-10 (AM0010) with 5-FU and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC). ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
132. Jassowicz A, Liu L, Huang H, Hong DS, Naing A, Subbiah V, Piha-Paul SA, Toung J, Vijayaraghavan R, Zhang R, Kang H, Fu S, Tsimberidou AM, Lu C, Eng C, Moulder S, Kopetz S, Amaria R, Meric-Bernstam F, Janku F. Targeted methylation sequencing of plasma cell-free DNA identifies patients with advanced breast, colorectal, non-small cell lung cancer, melanoma with poor outcomes. ESMO 2017 Congress, 2017. e-Pub 2017.
133. Naing A, Infante JR, Wong DJL, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver N, Ratti N, Hung A, Vlasselaer PV, Brown GL, Oft M, Tannir NM. Efficacy of PEGylated Human IL-10 (AM0010) in Combination with anti-PD-1 in Renal Cell Cancer. ESMO 2017 Congress, 2017. e-Pub 2017.
134. Naing A, Infante JR, Wong DJL, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Vlasselaer PV, Brown GL, Oft M, Tannir NM. Efficacy and safety of pegylated human IL-10 (AM0010) in combination with an anti-PD-1 in renal cell cancer. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
135. George GC, Mendoza T, Iwuayanwu E, Anderson K, Piha-Paul S, Naing A, Wang XS, Hong DS, Cleeland CS. Patient-reported symptom interference with activity-related and mood-related functioning in patients with advanced cancer in a phase I clinical trials clinic. International Society for Quality of Life Research (ISOQOL), 2017. e-Pub 2017.
136. Subbiah IM, Hess KR, Fujii T, Lui A, Subbiah V, Naing A, Hong DS. Integration of Supportive Care in Immuno-oncology Trials: Investigating the incidence and severity of immune related toxicities among older adults vs mid age patients on immunotherapy-based phase I clinical trials. 2017 Palliative and Supportive Care in Oncology Symposium, 2017. e-Pub 2017.
137. Subbiah IM, Hess KR, Fujii T, Alshawa A, Lui A, Roy S, Khanji R, Subbiah V, Naing A, Hong DS. Immuno-oncology and the elderly: A comparative analysis of participation and toxicities of senior adults aged 65 years and above vs mid age and adolescent/young adult patients on immunotherapy-based phase I clinical trials. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
138. Creasy C, Haymaker C, M-A F, Singh G, Tapia C, Painter JM, Meric‐Bernstam F, Bernatchez C, Naing A. Impact of anti‐PD1 on TIL phenotype and function. Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting, 2017. e-Pub 2017.
139. Habra MA, Campbell M, Jimenez C, Karp D, Hong D, Subbiah V, Pant S, Painter J, Khan S, Bernatchez C, Stephen B, Alshawa A, Tapia C, Mendoza T, Colen R, Hess K, Meric‐Bernstam F, Naing A. Efficacy of pembrolizumab (MK‐3475) in patients with adrenocortical carcinoma. Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting, 2017. e-Pub 2017.
140. Varadhachary GR, Raghav KSP, Pant S, Janku F, Fu S, Hong DS, Piha-Paul SA, Colen RR, Subbiah V, Painter J, Tsimberidou AM, Stephen B, Karp DD, McQuinn L, Mendoza TR, Hess KR, Meric-Bernstam F, Naing A. Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients with Cancer of Unknown Primary. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
141. Moehrmann L, Huang HJ, Hong DS, Tsimberidou AM, Fu S, Piha-Paul SA, Subbiah V, Karp DD, Naing A, Krug A, Enderle D, Priewasser T, Noerholm M, Eng C, Kopetz S, Skog J, Meric-Bernstam F, Janku F. Liquid biopsies of plasma exosomal nucleic acids, plasma cell-free DNA, and survival of patients with advanced cancers. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
142. Parseghian C, Patnana M, Bhosale P, Hess K, Kopetz S, Overman M, Naing A, Piha-Paul S, Subbiah V, Hong D, Le H, Pant S. Evaluating for pseudoprogression in colorectal and pancreatic tumors treated with immunotherapy. ESMO 19th World Congress on Gastrointestinal Cancer, 2017. e-Pub 2017.
143. Marabelle A, Parikh A, Shapiro G, Vargas A, Naing A, Meric‐Bernstam F, Reyderman L, Bao X, Binder T, Ren M, Siu A, Xu L, Liu M, Dayal S, Bhagawati‐Prasad V, Tchakov, Owa IT, Ooi CE, Hong DS. Phase I study of E7046, a novel PGE2 receptor type 4 inhibitor, in patients with advanced solid tumors with high myeloid infiltrate: effects on myeloid and T‐lymphoid cell-mediated immunosuppression. Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting, 2017. e-Pub 2017.
144. Naing A, Wong DJL, Infante JR, Patel MR, Pant S, Chmielowski B, Janku F, Tapia C, Ratti N, Vlasselaer PV, Brown GL, Hung A, Oft M, Diab A. PEGylated human IL-10 (AM0010) in combination with pembrolizumab in anti-PD1 and CTLA 4 refractory melanoma. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
145. Sen S, Hess K, Hong D, Naing A, Piha-Paul S, Janku F, Fu S, Liu H, Jiang Y, Khanji R, Karp D, Tsimberidou A, Tannier N, Meric-Bernstam F, Subbiah V. Development of a novel prognostic scoring system for patient selection in immune checkpoint inhibitor phase I clinical trials. 2017 AACR Annual Meeting, 2017. e-Pub 2017.
146. Kheder E, Huang HJ, Wu A, Hong DS, Piha-Paul SA, Karp DD, Fu S, Subbiah V, Tsimberidou AM, Naing A, Diab A, Javle M, Kopetz S, Sood AK, Kurie JM, Meric-Bernstam F, Gleeson M, Janku F. Detection of circulating antibodies against KRAS in patients with advanced cancers. 2017 AACR Annual Meeting, 2017. e-Pub 2017.
147. Sakamuri D, Kato S, Huang HJ, Naing A, Holley VR, Patel S, Piha-Paul SA, Tsimberidou AM, Hong DS, Meric-Bernstam F, Janku F. Dose escalation study of vemurafenib with crizotinib or sorfenib in patients with BRAF-mutated advance cancers. ESMO 2017 Congress, 2017. e-Pub 2017.
148. Naing A, Fu S, Tsimberidou AM, Pant S, Piha-Paul SA, Janku F, Hong DS, Colen RR, Carter BW, Evans E, Tawbi HA, Karp DD, Subbiah V, Dev R, Hess KR, Ueno NT, Simon GR, Overman MJ, Coleman RL, Meric-Bernstam F. Phase IB study to evaluate the safety of selinexor in combination with multiple standard chemotherapy agents in patients with advanced malignancies. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
149. Wong DJ, Schneider JG, Aljumaily R, Korn MW, Autio K, Infante JR, Patel MR, Papadopoulos K, Naing A, Gabrail N, Munster P, Goldman J, Van Vlasselaer P, Hung A, Brown G, Oft M, Garon EB. Efficacy and immune activation with PEGylated human IL-10 (AM0010) in combination with an anti-PD1 in advanced NSCLC: Update. ESMO Congress 2017, 2017. e-Pub 2017.
150. Hecht JR, Naing A, Falchook GS, Patel MR, Infante JR, Aljumaily R, Wong DJL, Autio KA, Wainberg ZA, Javle MM, Bendell JC, Pant S, Hung A, Van Vlasselaer P, Brown GL, Oft M, Papadopoulos K. Immunologic and objective tumor responses to PEGylated human IL-10 (AM0010) with 5-FU/LV and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC). ESMO 19th World Congress on Gastrointestinal Cancer, 2017. e-Pub 2017.
151. Ott PA, Naing A, Ramaswamy G, Margolin K, Moles M, Gaynor R, Goldstein MJ, Hu-Lieskovan S. An open-label, phase IB study of NEO-PV-01 + adjuvant with nivolumab in patients with melanoma, non-small cell lung carcinoma, or transitional cell carcinoma of the bladder. 42nd ESMO Congress, ESMO 2017, 2017. e-Pub 2017.
152. Groisberg R, Subbiah V, Hong D, Janku F, Piha-Paul S, Naing A, Benjamin R, Kumar Putal S, Somaiah N, Conley A. Characteristics and outcomes of patients with advanced sarcoma enrolled in early phase immunotherapy trials. 2017 AACR Annual Meeting, 2017. e-Pub 2017.
153. Groisberg R, Hong DS, Janku F, Jiang Y, Wei C, Karp DD, Tsimberidou AM, Naing A, Bhalla KN, Meric-Bernstam F, Subbiah V. SWI/SNF complex subunit aberrations in diverse cancers: Next-generation sequencing of 539 patients. ASCO 2017 Annual Meeting, 2017. e-Pub 2017.
154. Naing A, Hu-Lieskovan S, Govindan R, Margolin KA, Moles MA, Gaynor R, Goldstein MJ, Ott PA. An open-label, phase Ib study of NEO-PV-01 + adjuvant with nivolumab in patients with melanoma, non-small cell lung carcinoma, or transitional cell carcinoma of the bladder. ASCO Annual Meeting 2017, 2017. e-Pub 2017.
155. Janku F, Huang HJ, Shroff RT, Javle M, Conley AP, Raina A, Holley VR, Naing A, Karp DD, Fogelman D, Kaseb AO, Luthra R, Karlin-Neumann GA, Meric-Bernstam F. Detection and monitoring of IDH mutations in unamplifıed plasma cell-free DNA in patients with advanced cancers treated with IDH inhibitors. 2017 AACR Annual Meeting, 2017. e-Pub 2017.
156. Naing A, Papadopoulos KP, Autio KA, Wong DJ, Patel M, Falchook G, Pant S, Ott PA, Whiteside M, Patnaik A, Mumm J, Janku F, Chan I, Bauer T, Colen R, VanVlasselaer P, Brown GL, Tannir NM, Oft M, Infante J. Immune activation by PEGylated human IL-10 (AM0010) and anti-tumor activity in renal cancer alone and in combination with anti-PD-1. SITC 31st Annual Meeting 2016, 2016. e-Pub 2016.
157. Anderson C, Tang C, Schoenhals J, Tsouko E, Heymach J, de Groot P, Chang J, Hess KR, Diab A, Sharma P, Allison J, Naing A, Hong D, Welsh J. Neutrophill count predicts survival in patients on ipilimumab with radiation. SITC 31st Annual Meeting 2016, 2016. e-Pub 2016.
158. Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook G, Pant S, Whiteside M, Rasco D, Patnaik A, Bendell JC, Bauer TM, Colen RR, Hong D, Vlasselaer P, Brown GL, Oft M, Tannir N, Infante JR. Anti-tumor activity of PEGylated human IL-10 (AM0010) in renal cancer alone and in combination with anti-PD1. ESMO 2016 Congress, 2016. e-Pub 2016.
159. Naing A, Goel S, Curti B, Weise A, Eder JP, Marshall S, Morehouse C, Li X, Karakunnel JJ, Infante J. A Phase 1 first-in-human study of MEDI0680, an anti-PD-1 monoclonal antibody (mAb) in adult patients (pts) with advanced tumors. ESMO 2016, 2016. e-Pub 2016.
160. Tang C, Welsh JW, de Groot P, Massarelli E, Chang JY, Hess KR, Curan MA, Cabanillas ME, Subbiah V, Fu S, Tsimberidou AM, Karp DD, Gomez DR, Komaki R, Sharma P, Naing A, Hong DS. Phase I trial combining ipilimumab + high dose stereotactic radiation: Results and serum immune correlates. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
161. George G, Iwuanyanwu EC, Yusuf A, Anderson KO, Piha-Paul SA, Naing A, Janku F, Subbiah V, Wang XS, Shi Q, Mendoza TR, Hong DS, Cleeland CS. Symptom clusters in patients with advanced cancer in an early-phase clinical trials clinic. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
162. Papadopoulos KP, Naing A, Infante JR, Autio KA, Oft PA, Wong DJL, Falchook GS, Patel MR, Pant S, Whiteside M, Mumm JB, Chan IH, Bendell JC, Rasco DW, Shih KC, Javle MM, Bauer TM, Colen RR, Van Vasselaer P, Oft M. Anti-tumor activity of PEGylated human IL-10 (AM0010) in patients with pancreatic or colorectal cancer. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
163. Westin SN, Stashi E, pal N, Urbauer DL, Janku F, Piha-Paul SA, Naing A, Tsimiberidou AM, Fu Hong DS, Subbiah V. Phase I trial of paclitaxel, bevacizumab, and temsirolimus in advanced solid malignancies. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
164. Reilley M, Biley AM, Subbiah V, Janku F, Naing A, Falchook GS, Karp DD, Piha-Paul SA, Tsimberidou AM, Fu S, Zinner R, Lim JA, Bean SA, Bass A, Montez S, Vence LM, Sharma P, Allison JP, Meric-Bernstam F, Hong DS. Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
165. Cascone T, Hess KR, Piha-Paul SA, Hong DS, Subbiah IM, Bhatt T, Fu S, Naing A, Janku F, Karp DD, Meric-Bernstam F, Heymach J, Subbiah V. Safety, toxicity and activity of multi-kinase inhibitor vandetanib in combination with everolimus in advanced solid tumors. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
166. Naing A, Gelderblom H, Gainor JF, Forde PM, Butler M, C-C L, Sharma S, Ochoa de Olza M, Schellens JHM, J-C S, Taylor MH, Silva AP, Li Z, Bilic S, Cameron S, Infante JR. A first-in-human phase I study of the anti-PD-1 antibody PDR001 in patients with advanced solid tumors. 2016 ASCO Annual Meeting, 2016. e-Pub 2016.
167. Johnson A, Khotskaya Y, Brusco L, Zeng J, Holla V, Bailey AM, Litzenburger B, Sanchez N, Shufean MA, Piha-Paul SA, Subbiah V, Hong DS, Naing A, Routbort M, Shaw KR, Mills GB, Mendelsohn J, Meric-Bernstam F. Clinical utilization of precision oncology decision support for genomically-informed cancer therapy. ASCO Annual Meeting 2016, 2016. e-Pub 2016.
168. Naing A, Papadopoulos KP, Infante JR, Wong DJL, Autio KA, Oft PA, Falchook GS, Patel MR, Pant S, Patnaik A, Mumm JB, Whiteside M, Chan IH, Bendell JC, Bauer TM, Janku F, Colen RR, Tannir NM, Van Vlasselaer P, Oft M. Clinical activity and safety of pegylated human IL-10 (AM0010) in combination with anti-PD1. 2016 ASCO Annual Meeting, 2016. e-Pub 2016.
169. Paez-Arango N, Evans K, Zhao M, Yuca E, ScOft S, Kim C, Naing A, Meric-Bernstam F. Nuclear export inhibitor selinexor (KPT-330) demonstrates anti-tumor efficacy alone and in combination with chemotherapy in multiple breast cancer models. AACR 107th Annual Meeting 2016, 2016. e-Pub 2016.
170. Naing A, Pant S, Fu S, Colen R, Painter J, Banerjee U, Khan S, McQuinn L, Stephen B, Gong J, Mendoza T, Hess K, Meric-Bernstam F, Tannir N. Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients with Renal Medullary Carcinoma. Fifteenth International Kidney Cancer Symposium, 2016. e-Pub 2016.
171. Fujii T, Colen R, Bilen M, Hess K, Jajjar J, Suarez-Almazor M, Alshawa A, Hong D, Stephen B, Janku F, Subbiah V, Kato S, Karp D, Piha-Paul S, Tsimberidou A, Fu S, Sharma P, Meric-Bernstam F, Naing A. Incidence of immune-related adverse events in patients who received immunotherapy and radiographic analysis to predict pneumonitis. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, 2016. e-Pub 2016.
172. Papadopoulos KP, Crittenden MR, Johnson ML, Lockhart AC, Moore KN, Falchook GS, Formenti S, Carvajal RD, Leidner RS, Naing A, Rosen LS, Weiss GJ, Iii WC, Gao B, Paccaly A, Stankevich E, Trail P, Fury MG, Lowy I. A first-in-human study of REGN2810, a monoclonal, fully human antibody to programmed death-1 (PD-1), in combination with immunomodulators including hypofractionated radiotherapy (hfRT). ASCO Annual Meeting 2016, 2016. e-Pub 2016.
173. Dembla V, Ray D, Lockett P, Fullmer C, Subramanian H, Subbiah V, Fu S, Janku F, Tsimberidou AM, Naing A, Piha-Paul SA, Hong DS, Pant S, Miller VA, Lim J, Le H, Karp DD. Drug development in the MD Anderson Cancer Center (MDACC) Clinical Translational Research Center (CTRC) - 2011-2015: The challenge of precision medicine in a very broad playing field. 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, 2016. e-Pub 2016.
174. Paez Arango N, Evans KW, Zhao M, Yuca E, Scott SM, Janku F, Ueno NT, Tripathy D, Kim C, Naing A, Meric-Bernstam F. Selinexor, a selective inhibitor of nuclear export, demonstrates efficacy in preclinical models of triple negative breast cancer. San Antonio Breast Cancer Symposium (SABCS), 2016. e-Pub 2016.
175. Fujii T, Vibat CR, Karp DD, Piha-Paul SA, Subbiah V, Tsimberidou AM, Fu S, Hong DS, Huang HJ, Madwani K, Andrews DL, Hancock S, Naing A, Luthra R, Kee BK, Kopetz S, Erlander MG, Melnikova V, Meric-Bernstam F, Janku F. Circulating tumor DNA assay performance for detection and monitoring of KRAS mutations in urine from patients with advanced cancers. AACR 107th Annual Meeting 2016, 2016. e-Pub 2016.
176. Madwani K, Huang HJ, Shelton DN, Fu S, Tsimberidou AM, Piha-Paul SA, Naing A, Hong DS, Karp DD, Andrews DL, Cabrillo G, Kopetz ES, Luthra R, Kee BK, Eng C, Morris VK, Karlin-Neumann GA, Meric-Bernstam F, Janku F. Quantity of KRAS mutations in cell-free DNA is associated with survival of patients with advanced cancers. AACR 107th Annual Meeting 2016, 2016. e-Pub 2016.
177. Infante JR, Naing A, Papadopoulos KP, Autio KA, Oft PA, Wong DJ, Falchook GS, Patel M, Pant S, Whiteside M, Mumm JB, Chan IH, Bendell JC, Bauer TM, Janku F, Javle M, Colen RR, Tannier NM, Oft M. Anti-tumor activity of PEGylated human IL-10 (AM0010) in patients with advanced solid tumors. AACR 107th Annual Meeting 2016, 2016. e-Pub 2016.
178. George G, Iwuanyanwu EC, Anderson KO, Piha-Paul SA, Wheler JJ, Zinner R, Naing A, Tsimberidou AM, Janku F, Subbiah V, Cleeland CS, Mendoza TR, Hong DS. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a phase I clinic. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
179. Tang C, Naing A, de Groot P, Chang JY, Massarelli E, Parkhurst K, Erdman D, Barrientes S, Fok J, Subbiah V, Fu S, Tsimberidou A, Karp D, Gomez DR, Heymach J, Hahn SM, Komaki RU, Hong DS, Welsh JW. Phase 1 study of ipilimumab and stereotactic radiation targeting liver or lung lesions in patients with advanced malignancies. 2015 ASTRO's 57th Annual Meeting, 2015. e-Pub 2015.
180. Infante JR, Goel S, Tavakkoli F, Marshall S, Robbins PB, D'Angelo G, Gribbin MJ, Karakunnel JJ, Naing A. A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate MEDI0680, an anti-programmed cell death-1 antibody, in patients with advanced malignancies. ASCO 2015 Annual Conference, 2015. e-Pub 2015.
181. Goldstein JB, Tang C, Hong DS, Subbiah V, Janku F, Hess KR, Fu S, Karp DD, Naing A, Tsimberidou AM, Wheler JJ, Zinner R, Javle MM, Varadhachary GR, Wolff RA, Fogelman DR, Meric-Bernstam F, Piha-Paul SA. Evolution of phase 1 trials for patients with advanced pancreatic cancer: An update on the experience from MD Anderson Cancer Center. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
182. Subbiah IM, Janku F, Tsimberidou AM, Naing A, Subbiah V, Wheler JJ, Zinner RG, Eng C, Overman MJ, Kopetz S, Palmer GA, Hong DS. Next-generation sequencing of advanced, relapsed colorectal adenocarcinoma (CRC) to reveal mutations affecting Wnt, MAPK and PI3K pathway signaling: Emergence of novel combinatorial strategies. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
183. Infante JR, Goel S, Tavakkoli F, Marshall S, Robbins PB, D'Angelo G, Gribbin MJ, Karakunnel JJ, Naing A. A phase I, multicenter, open-label, first-in-human study to evaluate MEDI0680, an anti-programmed cell death-1 antibody, in patients with advanced malignancies. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
184. Infante JR, Naing A, Papadopoulous KP, Autio KA, Ott PA, Lee Wong DJ, Falchook GS, Patel MR, Pant S, Whiteside M, Bendell JC, Bauer TM, Janku F, Javle MM, Hong DS, Oft M. A first-in-human dose escalation study of PEGylated recombinant human IL-10 (AM0010) in advanced solid tumors. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
185. Wagner MJ, Hess KR, Hong DS, Tang C, Naing A, Fu S, Janku F, Piha-Paul S, Zinner RG, Wheler JJ, Tsimberidou AM, Patel S, Somaiah N, Ravi V, Benjamin RS, Meric-Bernstam F, Subbiah V. Validation of the Royal Marsden Hospital (RMH) prognostic score in 100 patients with advanced sarcoma enrolled in early phase clinical trials at a major cancer center. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
186. Janku F, Huang HJ, Claes B, Falchook GS, Fu S, Tsimberidou AM, Hong DS, Naing A, Wheler JJ, Piha-Paul SA, Karp DD, Subbiah V, Zinner RG, Ramzanali N, Luthra R, Patel SP, Kopetz ES, Sablon E, Maertens G, Kurzrock R, Meric-Bernstam F. Rapid, automated BRAF mutation testing of cell-free DNA from plasma of patients with advanced cancers using the novel Idylla platform. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
187. Cascone T, Hess KR, Piha-Paul S, Hong DS, Roxas M, Subbiah IM, Fu S, Naing A, Janku F, Karp D, Sherman SI, Meric-Bernstam F, Heymach JV, Subbiah V. A phase I study of everolimus (mTOR inhibitor) in combination with vandetanib (multikinase inhibitor of VEGFR, EGFR, and RET) in advanced solid tumors including molecularly matched aberrations. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, 2015. e-Pub 2015.
188. Subbiah V, Murthy R, Hong DS, Brown RE, Prins R, Hosing C, mcGuire M, Naing A, Fu S, Chou T, Lin Q, Guevarra RP, Conley A, Kaur I, Meric-Bernstam F, Bosch M. Clinical and immunopathological effects following image-guided intratumoral injection of activated, autologous dendritic cells in patients with advanced solid cancers. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
189. Subbiah V, Hong DS, Amini B, Piha-Paul S, Fernandez JG, Fu S, Tsimberidou AM, Naing A, Janku F, Karp DD, Overman M, Eng C, Kopetz S, Meric-Bernstam F, Falchook GS. Phase I dose escalation study fo the oral multi-kinase VEGF inhibitor regorafenib and the anti-EGFR monoclonal antibody cetuximab in patients with advanced solid tumors including colorectal cancer. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, 2015. e-Pub 2015.
190. Falchook GS, Dowlati A, Naing A, Gribbin MJ, Jenkins DW, Chang LL, Lai DW, Smith DC. Phase 1 Study of MEDI0639 in Patients With Advanced Solid Tumors. ASCO 2015 Annual Meeting, 2015. e-Pub 2015.
191. Infante JR, Naing A, Papadopoulos KP, Autio KA, Ott PA, Wong DJ, Falchook GS, Patel M, Pant S, Whiteside M, Bendell JC, Bauer TM, Janku F, javle M, Colen R, Tannir N, Oft M. PEGylated human IL-10 (AM0010) in advanced solid tumors. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, 2015. e-Pub 2015.
192. Piha-Paul S, Goldstein J, Hess K, Fu S, Hong DS, Janku F, Karp D, Naing A, Subbiah V, Tsimberidou AM, Wheler JJ, Zinner R, Mills GB, Meric-Bernstam F. Phase II Study of the PARP Inhibitor Talazoparib (BMN-673) in advanced cancer patients with somatic alterations in BRCA1/2, mutations/deletions in PTEN or PTEN loss, a homologous recombination defect, mutations/deletions in other BRCA pathway genes and germline mutation S in BRCA1/2 (not breast or ovarian cancer). 2015 AACR Annual Meeting, 2015. e-Pub 2015.
193. Park H, Garrido-Laguna I, Naing A, Fu S, Falchook GS, Piha-Paul SA, Wheler JJ, Hong DS, Subbiah V, Tsimberidou AM, Kaseb AO, Oki Y, Zinner R, Patel S, Velez Bravo VM, Fanale MA, Meric-Bernstam F, Kurzrock R, Janku F. Phase I study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancies. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
194. Wheler JJ, Yelensky R, Stephen B, Hong DS, Zinner R, Subbiah V, Fu S, Karp DD, Falchook GS, Naing A, Tsimberidou AM, Piha-Paul SA, Janku F, Li Y, Lee JJ, Miller VA, Meric-Bernstam F, Kurzrock R. Prospective study comparing outcomes in patients with advanced malignancies on molecular alteration-matched versus non-matched therapy. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
195. Janku F, Vibat CR, Falchook GS, Huang HJ, Hong DS, Piha-Paul SA, Subbiah V, Ramzanali NM, Hancock S, Naing A, Karp DD, Nitti G, Cabrilo G, Luthra R, Patel SP, Overman MJ, Kotetz S, Erlander MG, Melnikova V, Meric-Bernstam F. Low frequency KRAS G12/13 mutations in urine cell-free (cf) DNA from patients with BRAF V600E-mutant advanced cancers. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
196. Kato S, Janku F, Piha-Paul SA, Naing A, Karp DD, Tsimberidou AM, Subbiah V, Zinner R, W-J H, Javle MM, Parkhurst KL, Ramzanali NM, Kurzrock R, Meric-Bernstam F, Chae YK, Kim K, Falchook GS. Phase I study of combination vemurafenib, carboplatin, and paclitaxel in patients (pts) with BRAF-mutant advanced cancer. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
197. Naing A, Fu S, Habra MA, Chugh R, Kebebew E, Russell J, Welshans D, Fassnacht M, Kroiss M, M-E G, Ijzerman M, Plaunt MR, Mohideen P, Phillips M, Smith DC. ATR-101 phase 1 clinical study for adrenocortical carcinoma. 2015 ASCO Annual Meeting, 2015. e-Pub 2015.
198. Subbiah IM, Janku F, Tsimberidou AM, Naing A, Subbiah V, Wheler JJ, Zinner RG, Eng C, Overman MJ, Kopetz S, Hong DS. Concurrent aberrations in the Wnt, MAPK and PI3K pathways identified through next generation sequencing of relapsed refractory colorectal adenocarcinoma (CRC): Implications for future therapeutic trials. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
199. Kato S, Naing A, Falchook G, Holley VR, Velez-Bravo VM, Patel S, Zinner RG, Piha-Paul SA, Tsimberidou AM, Hong DS, Kurzrock R, Meric-Bernstam F, Janku F. Overcoming BRAF/MEK resistance using vemurafenib with crizotinib or sorafenib in patients with BRAF-mutant advanced cancers: phase I study, 2015. e-Pub 2015.
200. Janku F, Hong DS, Atkins JT, Karp DD, Tsiimberidou AM, Piha-Paul SA, Subbiah V, Naing A, Fu S, Moulder SL, Tripathy D, Meric-Bernstam F, Wheler JJ. Everolimus, Letrozole and Trastuzumab in estrogen receptor and HER2-positive patients with metastatic breast cancer and other solid tumors: Evaluating synergy and overcoming resistance. SABCS 2015, 2015. e-Pub 2015.
201. Huang HJ, Shelton DN, Fu S, Piha-Paul SA, Tsimberidou AM, Zinner RG, Wheler JJ, Naing A, Hong DS, Falchook GS, Kopetz S, Luthra R, Kee BK, Karlin-Neumann GA, Meric-Bernstam F, Janku F. Mulitplex KRAS G12/G13 mutation testing of 16ng of unamplified cell-free DNA from plasma of patients with advanced cancers using Droplet Digital PCR. 2015 AACR Annual Meeting, 2015. e-Pub 2015.
202. Khawaja MR, Madhusudanannair V, Ng C, Nick A, Janku F, Piha-Paul S, Coleman R, Soliman P, Fu S, Hong D, Karp D, Subbiah V, Tsimberidou A, Meric-Bernstam F, Lu K, Naing A. Phase I dose escalation study of temsirolimus in combination with metformin in patients with advanced cancers. AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, 2015. e-Pub 2015.
203. Naing A, Najat D, Peter A, Ralph Z, Subbiah V, Sergei G, Hsuan-Chu C, Joud H, Eugenie K, Nancy G. Aerosol interleukin-2 for the treatment of patients ≥12 years old with lung metastases from osteosarcoma: a phase I trial. SITC 29th Annual Meeting, 2014. e-Pub 2014.
204. Subbiah V, Agarwal R, Janku F, Tsimberidou AM, Patel S, Benjamin RS, Ludwig JA, Meade Anderson P, Araujo DM, Ravi V, Conley AP, Somaiah N, W-L W, Naing A, Zinner R, Hong DS, Meric-Bernstam M. Diversity and hertogeneity in molecular analysis of advanced sarcomas: the clinical, regulatory, and financial challenge for drug development and precision medicine. ASCO Annual Meeting 2014, 2014. e-Pub 2014.
205. Boland MG, Piha-Paul SA, Subbiah V, Brusco L, Herbrich SM, Baggerly KA, Routbort M, Patel K, Luthra R, Naing A, Fu S, Falchook GS, Hong DS, Wheler JJ, Janku F, Shaw K, Aldape KD, Mendelsohn J, Mills GB, Meric-Bernstam F. Clinical next-generation sequencing to identify actionable alterations in a phase I program. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
206. Janku F, Oki Y, Falchook GS, Subbiah V, Naing A, Garrido-Laguna I, Velez-Bravo VM, Hong DS, Westin JR, Nunez CA, Le F, Neelapu SS, Kwak LW, Shpall EJ, Wheler JJ, Barnes T, Patel A, Liang WS, Salhia B, Meric-Bernstam F, Kurzrock R, Fanale MA. Activity of the mTOR inhibitor sirolimus and HDAC inhibitor vorinostat in heavily pretreated refractory Hodgkin lymphoma patients. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
207. Wheler J, Janku F, Atkins JT, Moulder SL, Zinner R, Lee J, Falchook GS, Tsimberidou AM, Piha-Paul SA, Karp DD, Naing A, Fu S, Hong DS, Subbiah V, Stephens PJ, Yelensky R, Miller V, Kurzrock R, Meric-Bernstam F. PI3K/AKT/mTOR genomic alterations in 94 patients with metastatic breast cancer in the phase I clinic at MD Anderson: prevalence and association with response. ASCO Annual Meeting 2014, 2014. e-Pub 2014.
208. Huang HJ, Claes B, Falchook GS, Holley VR, Naing A, Piha-Paul SA, Tsimberidou AM, Zinner RG, Karp DD, FU S, Subbiah V, Hong DS, Wheler JJ, Stepanek VM, Cabrilo G, Luthra R, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Ivens T, Sablon E, Maertens G, Kurzrock R, Meric-Bernstam F, Janku F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform (Idylia™). 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, 2014. e-Pub 2014.
209. Bupathi M, Hajjar J, Hess K, Bean S, Karp D, Meric-Bernstam F, Naing A. Evaluation of drug reactions to anti-neoplastic agents in Phase I clinical trials. 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, 2014. e-Pub 2014.
210. Huang M, Parkhurst KL, Jiang JF, Moulder SL, Naing A, Wheler JJ, Hong DS, Piha-Paul S, Fu S, Tsimberidou A, Zinner R, Janku F, Kurzrock R, Falchook GS. HER2 extracellular domain (ECD) and HER2 single nucleotide polymorphisms (SNPs) in patients treated with combination trastuzumab, lapatinib, and bevacizumab. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
211. Subbiah V, Patel S, Benjamin RS, Agarwal R, Janku F, Ludwig J, Anderson PM, Araujo D, Ravi V, Conley AP, Somaiah N, Naing A, Hong DS, Meric-Bernstam F. Target-based therapeutic matching in early-phase clinical trials in patients with advanced sarcoma. Connective Tissue Oncology Society 2014 Annual Meeting, 2014. e-Pub 2014.
212. Bilen MA, Patel A, Hess KR, Muloz J, Busaidy N, Wheler J, Janku F, Falchook GS, Hong DS, Meric-Bernstam F, Habra MA, Naing A. Association between new onset hypothyroidism and clinical response in patients treated with tyrosine kinase inhibitor (TKI) therapy in phase I clinic trials. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
213. Livingston JA, Hess K, Fernandez JG, Naing A, Hong D, Patel S, Anderson P, Benjamin R, Ludwig J, Herzog C, Fu S, Wheler J, Falchook G, Tsimberidou AM, Piha-Paul S, Janku F, Rohren E, Meric-Bernstam F, Kurzrock R, Subbiah V. Eliciting early response signals from first in human clinical trials and validation of prognostic scores in aggressive biology bone cancers: the MD Anderson experience. ASCO Annual Meeting 2014, 2014. e-Pub 2014.
214. Liu X, Hou M, Wheler J, Naing A, Hong D, Tsimberidou AM, Piha-Paul SA, Zinner R, Falchook G, Janku F, Ramondetta L, Schmeler K, Lu K, Kurzrock R, Fu S. Differential effect of PIK3CA mutations and PTEN loss in patients with advanced endometrial cancers on matched therapy. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
215. Tsimberidou AM, Culotta K, Wistuba I, Fu S, Naing A, Falchook GS, Piha-Paul S, Zinner RG, Siddik ZH, He G, Said R, Hess K, Stewart D, Kurzrock R, Issa JP. Phase I study of 5-azacytidine and oxaliplatin in patients with advanced cancers relapsed or refractory to platinum compounds. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
216. M-M H, Bellido J, Naing A, Falchook G, Hess K, Zinner R, Janku F, Wheler J, Subbiah V, Hong DS, Piha-Paul S, Tsimberidou A, Karp D, Kurzrock R, Meric-Bernstam F, Fu S. A phase I trial of pazopanib and vorinostat: the role of TP53 mutations. ASCO Annual Meeting 2014, 2014. e-Pub 2014.
217. Naing A, Habra MA, Fu S, Piha-Paul SA, Ijzerman M, Hein JP, Phillips M, Smith DC. Phase I study of ATR-101 in adrenocortical carcinoma (ACC): ATR-101-001. ASCO Annual Meeting 2014, 2014. e-Pub 2014.
218. Fu S, Nguyen E, Janku F, Subbiah V, Patel S, Naing A, Falchook G, Zinner R, Tsimberidou A, Hong DS, Piha-Paul J, Wheler J, Shi N, Bomalaski J, Hwu P, Meric-Bernstam F. Targeting argininosuccinate synthetase-deficient advanced solid tumors in a phase I trial of ADI-PEG20 plus cisplatin. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
219. Wheler J, Janku F, Moulder SL, Naing A, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Miller V, Stephens PJ, Valero V, Meric-Bernstam F, Kurzrock R. Anastrozole and everolimus in hormone receptor-positivie metastatic breast cancer: activity and associations with molecular alterations in the PI3K/AKT/mTOR pathway. SABCS, 2014. e-Pub 2014.
220. Janku F, Falchook GS, Piha-Paul SA, Naing A, Holley VR, Hong DS, Subbiah V, Karp DD, Zinner RG, Fu S, Wheler JJ, Meric-Bernstam F, Stepanek VM, Luthra R, l L, Hassaine L, Kosco K, Erlander MG. Digital droplet PCR detection and monitoring of BRAF mutations in cell-free urinary DNA of patients with metastatic cancers or Erdheim-Chester disease. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
221. Subbiah V, Corrales-Medina FF, Herzog CE, Hess KR, Egas Bejar DE, Hong DS, Falchook GS, Meade Anderson P, Nunez C, Huh WW, Naing A, Tsimberidou AM, Wheler JJ, Piha-Paul SA, Janku F, Kleinerman E, Kurzrock R. Outcomes of pediatric cancer patients enrolled in phase I clinical trials designed for adults: experience from a major cancer center. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
222. Tang C, Jardim DF, De Melo Galgiato D, Falchook GS, Hess K, Fu S, Wheler JJ, Zinner RG, Naing A, Tsimberidou AM, Meric-Bernstam F, Hong DS. Analysis of 1115 patients tested for MET amplification and therapy response in the MD Anderson phase I clinic. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
223. Tsimberidou, Ye Y, Wheler J, Falchook G, Hong D, Naing A, Fu S, Kurzrock R, Piha-Paul S, Janku F, Zinner R, Moulder S, Subbiah V, Karp D, Meric-Bernstam F, Hwu P, Kies MS, Sherman SI, Wolff RA, Coleman R, Miller V, Aldape K, Broaddus R, Berry D, Hess K. Genomic profiling and precision medicine in 3,745 patients with advanced cancer. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
224. Janku F, Vibat CR, Falchook GS, Piha-Paul S, Naing A, Holley VR, Subbiah V, Wheler JJ, Meric-Bernstam F, Cabrilo G, Luthra R, Leppin L, Hassaine L, Kosco K, Erlander MG. Longitudinal monitoring of BRAF V600E mutation in urinary cell-free DNA of patients with metastatic cancers using droplet digital PCR. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
225. Janku F, Legendre B, Richardson K, Falchook GS, Naing A, Holley VR, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Zinner RG, Subbiah V, Tsimberidou AM, Karp DD, Stepanek VM, Cabrilo G, Luthra R, Meric-Bernstam F, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Kruempel A, Pope J, Cubrich C, Wu G, Shi Y, Lewis M, Kurzrock R. BRAF and KRAS mutation treating in plasma cell-free DNA with ICE-COLD PCR in patients with advanced cancers. 2014 AACR Annual Meeting, 2014. e-Pub 2014.
226. Legendre B, Richardson K, Falchook GS, Naing A, Holley VR, Fu S, Hong DS, Piha-Paul SA, Wheler JJ, Zinner RG, Subbiah V, Tsimberidou AM, Karp DD, Stepanek VM, Cabrilo G, Luthra R, Meric-Bernstam F, Bedikian AY, Kee BK, Eng C, Overman MJ, Kim KB, Kruempel A, Pope J, Cubrich C, Wu G, Lewis M, Kurzrock R, Janku F. BRAF and KRAS mutation testing in plasma cell-free DNA with ICE-COLD PCR in patients with advanced cancers. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
227. Liu X, George GC, Tsimberidou A, Naing A, Wheler J, Kopetz S, Fu S, Piha-Paul S, Eng C, Falchook G, Janku F, Garrett C, Karp D, Kurzrock R, Zinner R, Raghav K, Subbiah V, Meric-Bernstam F, Hong DS, Overman M. Rechallenge with anti-EGFR therapy in metastatic colorectal cancer: impact of intervening time interval and prior anti-EGFR response. ASCO 2014 Annual Meeting, 2014. e-Pub 2014.
228. Gordon NB, Bitar ND, Anderson P, Guma S, H-C C, McQuinn LM, Hein JP, Zinner R, Kleinerman ES, Naing A. Aerosol interleukin-2 for the treatment of patients ≥ 12 years old with osteosarcoma lung disease: a phase I/II study. AACR 2014 Annual Meeting, 2014. e-Pub 2014.
229. Ganesan P, Piha-Paul S, Naing A, Falchook G, Wheler J, Janku F, Zinner R, Laday L, Kies M, Tsimberidou A. Phase I Clinical Trial of Lenalidomide in Combination with Temsirolimus in Patient with Advanced Cancer. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
230. Hou M Liu X Wheler J, Naing A, Hong D, Bodurka D, Schmeler K, Tsimberidou A, Janku FZinner R, Piha-Paul S, Lu K, Wolff R, Kurzrock R, Fu S. Outcome Analyses of Patients with Metastatic Cervical Cancers in a Phase I Clinic. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
231. Bilen MA, Fu S, Hong DS, Wheler JJ, Abdelrahim M, Falchook GS, Tsimberidou AM, Janku F, Piha-Paul SA, Zinner RG, Kurzrock R, Naing A. Phase I trial of lenalidomide and valproic acid in patients with advanced cancer. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
232. Chae YK, Kim K, Hong DS, Falchook G, Piha-Paul S, Wheler J, Naing A, Fu S, Tsimberidou AM, Zinner R, Subbiah V, Stepanek V, Wolff R, Kurzrock R, Janku F. PIK3CA mutation, aspirin use and mortality in patients with metastatic colorectal cancer participating in early-phase clinical trials. 2013 AACR Annual Meeting, 2013. e-Pub 2013.
233. Falchook G, Hong D, Amin H, Fu S, Piha-Paul S, Janku F, Subbiah V, Naing A, Wheler JJ, Klevesath MB, Kohler K, Johne A, Bladt F, Kurzrock R. Phase I study of oral selective c-Met inhibitor EMD 1214063 in pts with advanced solid tumors. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
234. Haung HJ, Claes B, Falchook GS, Tsimberidou AM, Holley VR, Subbiah V, Zinner RG, Naing A, Karp DD, Piha-Paul SA, Wheler JJ, Fu S, Hong DS, Stepanek VM, Luthra R, Meric-Bernstam F, Ivens T, Sablon E, Maertens G, Kee BK, Kurzrock R, Scherer S, Janku F. BRAF mutation testing in cell-free DNA from plasma of patients with advanced cancers using a novel, rapid, automated molecular diagnostics prototype platform. AACR 2013, 2013. e-Pub 2013.
235. Gordon NB, Anderson P, Guma SR, Chien HC, McQuinn LM, Hein JP, Zinner RG, Kleinerman ES, Naing A. Clinical evaluation of aerosol IL-2 in patients with lung metastases to test feasibility and safety for future combination therapy using infused natural killer cells. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
236. Huang HJ, Claes B, Falchook GS, Devogelaere B, Naing A, Fu S, Piha-Paul SA, Hong DS, Holley VR, Tsimberidou AM, Stepanek VM, Kim KB, Angelo LS, Subbiah V, Wheler JJ, Rg Z, Karp DD, Luthra R, Sablon E, Maertens G, Meric-Bernstam F, Kurzrock R, Scherer S, Janku F. BRAF mutation testing of archival tumor samples with a novel, rapid, fully-automated molecular diagnostics prototype platform. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
237. Subbiah I, Subbiah V, Naing A, Fu S, Kaseb A, Falchook G, Tan D, Herzog C, Janku F, Kurzrock R. Targeted therapies in Early-phase trials for the treatment of advanced fibrolamellar hepatocellular carcinoma. Gastrointestinal Cancer Symposium, 2013. e-Pub 2013.
238. Huang HJ, Devogelaere B, Falchook G, Fu S, Angelo LS, Hong DS, PIha-Paul SA, Naing A, Holley VR, Tsimberidou AM, Stepanek VM, Kim K, Subbiah V, Wheler JJ, Zinner R, Wolff R, Sablon E, Maertens G. BRAF mutation testing with a novel, rapid, fully automated molecular diagnostics prototype platform. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
239. Subbiah I, Janku F, Naing A, Wolff R, fu S, Hong D, Kaseb A, Herzog C, Kurzrock R, Subbiah V. Theranostic profiling of adolescents and young adults (AYA) with advanced fibrolamellar hepatocellular carcinoma identifies aberrant activation of the PI3K/AKT/MTOR signaling cascade. 2013 ASCO Annual Meeting, 2013. e-Pub 2013.
240. Ganesan P, Moulder S, Janku F, Naing A, Fu S, Tsimberidou AM, Hong DS, Stephens P, Yelensky R, Meric F, Kurzrock R, Wheler JJ. PIK/AKT/MTOR pathway activiationin triple negative berast cancer and outcomes with matched therapy in phase I clinical trials: Response in both patients with and without direct molecular alterations. Thirty-Sixth Annual CTRC-AACR San Antonio Breast Cancer Symposium, 2013. e-Pub 2013.
241. Subbiah IM, Janku F, Tsimberidou AM, Naing A, Kaseb AO, Hong DS, Subbiah V, Hess KR, Akmal O, Falchook GS, Kurzrock R. Characteristics and outcomes of patients with advanced hepatocellular carcinoma treated on phase I trials. 2013 Gastrointestinal Cancers Symposium, 2013. e-Pub 2013.
242. Wheler JJ, Moulder S, Naing A, Stephens P, Kurzrock R, Janku F, Piha-Paul S, Falchook G, Zinner R, Tsimberidou A, Fu S, Hong D, Atkins J, Cronin M, Yelensky R. A Dose-Escalation Study of Anastrozole and Everolimus in Patients with Advanced Gynecologic and Breast Malignancies: Tolerance, Biological Activity, and Molecular Alterations in the PI3K/AKT/mTOR Pathway. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
243. Abdelrahim M, Naing A, Dalal S, Wheler JJ, Hess K, Fu S, Hong DS, Janku F, Falchook GS, Ilustre A Piuamg F Kurzrock R. Olanzapine for cachexia in patients with advanced cancer. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
244. Hou M, Liu X, Piha-Paul SA, Janku F, Wheler JJ, Naing A, Bodurka D, Schmeler K, Lu K, Zinner RG, Hong DS, Meric-Bernstam, F, Kurzrock R, Fu S. Target-matched therapies in patients with advanced cervical cancers harboring PIK3CA mutations and/or PTEN loss. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
245. Westin S, Smart ML, Pal N, Urbauer DL, f J, Wheler JJ, Piha-Paul SA, Naing A, Tsimberidou A, Fu S, Falchook G, Hong D, Zinner R, Subbiah V, Culotta K, Lu KH, Coleman RL, Kurzrock R. Phase I trial of sorafenib, bevacizumab, and temsirolimus in advanced solid tumors. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
246. Tsimberidou A, Said R, Falchook G, Janku F Naing A, Zinner R, Blumenschein G, Fu S, Hong D, Piha-Paul S, Wheler J, Ye Y, Hess K, Palmer G, Wolff R, Kurzrock R. Outcome of patients with advanced cancer and KRAS mutation in phase I clinical trials. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
247. Agarwal R, Naing A, Falchook G, Wheler J, Fu S, Kurzrock. Retreatment after secondary resistance: A pilot study. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
248. Ganesan P, Piha-Paul S, Naing A, Falchook GS, Wheler J, Fu S, Hong D, Kurzrock R, Janku F, Laday S, Bedikian A, Kies M, Wolff R, Tsimberidou A. Phase I clinical trial of Lenalidomide in combination with Sorafenib in patients with advanced cancer. 2013 AACR Annual Meeting, 2013. e-Pub 2013.
249. Said R, Ye Y, Hong DS, Janku F, Fu S, Naing A, Wheler JJ, Kurzrock R, Thomas C, Palmer GA, Hess KR, Wolff RA, Tsimberidou AM. Characteristics and survival of patients with advanced cancer and TP53 mutations in phase I clinical trials. ASCO 2013 Annual Meeting, 2013. e-Pub 2013.
250. Janku F, Falchook GS, Piha-Paul SA, Naing A, Tsimberidou AM, Holley VR, Karp DD, Zinner RG, Fu S, Wheler JJ, Hong DS, Meric-Bernstam F, Stepanek VM, Luthra R, Leppin L, Hassaine L, Kosco K, Poole JC, Erlander MG. Detection and monitoring of BRAF and KRAS mutations in cell-free urinary DNA of metastatic cancer patients by droplet digital PCR. AACR 2013 Annual Meeting, 2013. e-Pub 2013.
251. Amin HM, Falchook GS, Fu, S, Hong DS, Tsimberidou AM, Naing A, Wheler JJ, Piha-Paul SA, Janku F, Klevesath MB, Jego V, Johne A, Kurzrock R. First-in-human phase I dose-escalation study of the oral selective C-met inhibitor EMD 1204831 in patients with advanced solid tumors. ASCO 2012 Annual Meeting, 2012. e-Pub 2012.
252. Janku F, Naing A, Falchook GS, Tsimberidou AM, Stepanak V, Fu S, Piha-Paul S, Luthra R, Hong DS, Kurzrock R. Target-based therapeutic matching in early-phase clinical trials in patients with advanced colorectal cancer and PIK3CA mutations. 2012 Gastrointestinal Cancers Symposium, 2012. e-Pub 2012.
253. Wheler J, Moulder S, Falchook G, Tsimberidou AM, Janku F, Naing A, Fu S, Piha-Paul S, Kurzrock R. Treatment with Hormonal Blockade in Estrogen Receptor-Positive Tumors and Correlation with Molecular Markers: a Phase I Pilot Study of Anastrozole in Combination with Everolimus, Bevacizumab, Sorafenib or Erlotinib. 2012 AACR Annual Meeting, 2012. e-Pub 2012.
254. Rodrigues H, Parsons H, Janku FNaing A, Wheler J, Tsimberidou A, Kurzrock R. A pilot study of temsirolimus and body composition. 2012 ASCO Annual Meeting, 2012. e-Pub 2012.
255. Subbiah IM, Subbiah V, Kaseb AO, Janku F, Wheler JJ, Naing A, Fu S, Piha-Paul S, Hong DS, Falchook GS, Tsimberidou AM, Kurzrock R. Characteristics and Outcomes of Patients with Gallbladder Cancer and Cholangiocarcinoma Referred to a Phase I Clinic. 2012 Gastrointestinal Cancers Symposium, 2012. e-Pub 2012.
256. Subbiah I, Kurzrock R, Naing A, Piha-Paul S, Falchook G, Hong DS, Wheler J, Fu S, Laday S, Tsimberidou AM. Phase 1 study of Lenalidomide in combination with Bevacizumab, Temsirolimus, or 5-fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) in patients with advanced cancers. AACR 2012 Annual Meeting, 2012. e-Pub 2012.
257. Madhusudanannair V, Janku F, Falchook GS, Hong DS, Wheler J, Naing A, Fu S, Piha-Paul S, El-Osta H, Luthra R, Tsimberidou AM. NRAS mutations in patients with advanced cancers treated with target-based therapies in early phase clinical trials. 2012 ASCO Annual Meeting, 2012. e-Pub 2012.
258. Ganesan, P, Piha-Paul S, Naing A, Falchook G, Wheler J, Fu S, Hong D, Kurzrock R, Janku F, Laday S, Bedikian AY, Kies M, Wolff R, Tsimberidou AM. Phase I clinical trial of Lenalidomide in combination with Sorafenib in patients with advance cancer. AACR 2013 Meeting, 2012. e-Pub 2012.
259. Naing A, Falchook G, Fu S, Amin HM, Piha-Paul S, Hong DS, Tsimberidou AM, Wheler JJ, Janku F, Klevesath MB, Jego V, Johne A, Kurzrock R. A Phase I Dose-escalation Study of EMD1214063, an Oral-selective cMET inhibitor, in Patients with Advanced Solid Tumors. 10th Annual Meeting of JSMO, 2012. e-Pub 2012.
260. Bilen MA, Naing A, Hong DS, Falchook GS, Fu S, Wen S, Wheler JJ, J-B D, Ewer M, Kurzrock R. Association between elevated blood pressure and clinical response in patients treated with anti-vascular endothelial growth factor (anti-VEGF) therapy in phase I clinical trials. 2012 ASCO Annual Meeting, 2012. e-Pub 2012.
261. Henary H, Hong DS, Falchook GS, Tsimberidou AM, George G, Wheler JJ, Fu S, Naing A, Piha-Paul, SA, Janku F, Kurzrock R. Targeted agents matched with tumor molecular aberrations: Review of 160 patients with advanced melanoma treated in a phase 1 clinic. ASCO 2012 Annual Meeting, 2012. e-Pub 2012.
262. Kurzrock R, Tsimberidou AM, Hong DS, Wheler JJ, Falchook GS, Fu S, Naing A, Janku F, Wen S, Berry D. Pursuing Molecular Stratification in Phase I Trials. 2012 AACR-EORTC-NCI, 2012. e-Pub 2012.
263. Janku F, Wheler JJ, Piha-Paul SA, Stepanek VM, Fu S, Hong DS, Naing A, Falchook GS, Moulder SL, Luthra R, Tsimberidou AM, Kurzrock R. Target-based therapeutic matching in patients with PIK3CA mutations and PTEN aberrations. AACR 2012 Annual Meeting, 2012. e-Pub 2012.
264. Subbiah I, Kurzock R, Naing A, Piha-Paul S, Falchook G, Hong DS, Wheler J, Fu S, Laday S, Tsimberidou AM. Phase I Study of Lenalidomide in Combination with Bevacizumab, Temsirolimus, or 5-fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) in Patients with Advanced Cancers. 2012 AACR Annual Meeting, 2012. e-Pub 2012.
265. Janku F, Broaddus R, Bakkar R, Hong DS, Stepanek VM, Naing A, Falchook G S, Fu S, Wheler J, Piah-Paul S, Moulder SL, Luthra R, Tsimberidou AM, Kurzrock R. PTEN Assessment and PI3K /mTOR Inhibitors: Importance of Simultaneous Assessment of MAPK Pathway Aberrations. 2012 ASCO Annual Meeting, 2012. e-Pub 2012.
266. Bilen MA, Naing A, Hong DS, Falchook G, Fu S, Wen S, Wheler J, J-B D, Ewer MS, Kurzrock R. Association between Elevated Blood Pressure and Clinical Response in Patients Treated with Anti-vascular Endothelial Growth Factor Therapy in Phase I Clinical Trials: The MD Anderson Cancer Center Experience. 2012 ASCO Annual Meeting, 2012. e-Pub 2012.
267. A N, Fu S, Arakawa K, Zinner R, Wheler J, Falchook G, Hong DS, Kurzrock R. TAS-106 in Combination with Carboplatin is Active in Patients with Refractory Non-Small Cell Lung Cancer and Ovarian Cancer. 10th Annual Meeting of JSMO, 2012. e-Pub 2012.
268. Janku F, Angenendt P, Diehl F, Fu S, Falchook G, Hong D, Naing A, Tsimberidou A, Wheler J Kurzrock R. Actionable Mutations in Circulating Tumor DNA and Response to Target-Based Therapies. 2012 AACR-EORTC-NCI, 2012. e-Pub 2012.
269. Said R, Hong DS, Wheler JJ, Naing A, Falchook GS, Fu S, Janku F, Zinner R, Piha-Paul SA, Waneke CL, Tsimberidou AM, Kurzrock R. P53 mutations in advanced cancers: Clinical characteristics and outcomes in a phase I setting. ASCO 2012 Annual Meeting, 2012. e-Pub 2012.
270. Tsimberidou AM, Hong DS, Wheler J, Wen S, Ye Y, Fu S, Piha-Paul S, Naing A, Falchook GS, Janku F, Kurzrock R. Personalized medicine: An update on 1,985 patients with advanced cancer at MD Anderson cancer center. WIN Symposium: Efficacy of biomarkers and personalized cancer therapeutics, 2012. e-Pub 2012.
271. Naing A, Fu S, Hong DS, Kurzrock R. Insulin Growth Factor-Receptor (IGF-1R) Antibody Cixutumumab combined with the mTOR Inhibitor Temsirolimus in patients with Metastatic Adrenocortical Carcinoma. ASCO 2012 Annual Meeting, 2012. e-Pub 2012.
272. Kurzrock R, Naing A, Falchook GS, Hong DS, Elekes A, Sumida T, Bricmont P, Kodama T, Motoyama M, Patil S, Lee J, Jones S, Infante J, Burris H, Bendell J. A phase 1, open-label, dose escalation, nonrandomized study to assess the maximum tolerated dose, dose limiting toxicity, and pharmacokinetics of OPB-31121 in subjects with advanced solid tumors. AACR-NCI-EORTC 2011, 2011. e-Pub 2011.
273. Hong DS, Naing A, Falchook GS, Piha-PAul S, Wheler JJ, Fu S, Tsimberidou AM, Hui D, Scott R, Khan R, Mistry R, Talley J, Chauhan S, Bermudez D, Stecher M, Simard J, Kurzrock R. A phase I study of MABp1, a first-in-human, first-true human monoclonal antibody against the IL-1 in patients with advanced cancers. [abstract]. AACR-NCI-EORTC 2011, 2011. e-Pub 2011.
274. Falchook GS, Fu S, Amin HM, Piha-Paul SA, Hong DS, Naing A, Klevesath MB, Mattiacci MR, Di Cara A, Kurzrock R. A phase I dose-escalation study of EMD 1214063, an oral selective c-Met inhibitor, in patients with advanced solid tumours. ESMO 2011, 2011. e-Pub 2011.
275. Garrido-Laguna I, Kurzrock R, Wheler JJ, Falchook GS, Piha-Paul SA, Fu S, Naing A, Hinojosa C, Mistry R, Scamardo A, Culotta KS, Ekmekcioglu S, Wen S, Camacho LH, Ivy SP, Hong DS. Dual inhibition of VEGF pathway: Phase I trial of bevacizumab and cediranib in advanced solid tumors. J Clin Oncol 29(15_suppl):3065, 2011. e-Pub 2011. PMID: 28022565.
276. Stephen B, Wheler JJ, Tsimberidou AM, Wen S, Naing A, Hong DS, Falchook GS, Piha-Paul SA, Fu S, Janku F, Moulder SL, Kurzrock R. Survival of 1,181 patients in a phase I clinic: The University of Texas M. D. Anderson Cancer Center experience. J Clin Oncol 29(15_suppl):2528, 2011. e-Pub 2011. PMID: 28022343.
277. Veasey Rodrigues H, Naing A, Hong DS, Falchook GS, Fu S, Wheler JJ, Tsimberidou AM, Moulder SL, Janku F, Wen S, Fessahaye SN, Golden EC, Westerhold DI, Ewer M, Kurzrock R. The role of the electrocardiogram (ECG) in phase I drug development in patients with cancer: The University of Texas M. D. Anderson Cancer Center experience with 8,966 ECGs. J Clin Oncol 29(15_suppl):2545, 2011. e-Pub 2011. PMID: 28022320.
278. Banerji U, Aghajanian C, Raymond E, Kurzrock R, Blanco-Codesido M, Oelmann E, Grinsted L, Burke W, Kaye SB, Naing A. First results from a phase I trial of AZD8055, a dual mTORC1 and mTORC2 inhibitor. J Clin Oncol 29(15_suppl):3096, 2011. e-Pub 2011. PMID: 28022492.
279. Fu S, Hong DS, Naing A, Wheler JJ, Falchook GS, Wen S, Howard A, Barber D, Nates JL, Price KJ, Kurzrock R. Outcome analyses after the first admission to an intensive care unit in patients with cancer enrolled into a phase I clinical trials program: When is the optimal time to trigger code status discussion?. J Clin Oncol 29(15_suppl):e13020, 2011. e-Pub 2011. PMID: 28019818.
280. Naing A, LoRusso P, Fu S, Hong DS, Anderson PM, Benjamin RS, Ludwig JA, Chen HX, Doyle LA, Kurzrock R. Cixutumumab combined with temsirolimus in patients with refractory Ewing's sarcoma. J Clin Oncol 29(15_suppl):10031, 2011. e-Pub 2011. PMID: 28021114.
281. Sun M, Falchook GS, Wheler JJ, Hong DS, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Moulder SL, Wen S, Mueller P, Kurzrock R. Association of VEGF single-nucleotide polymorphisms (SNPs) with response and toxicity in patients treated with bevacizumab. J Clin Oncol 29(15_suppl):e13560, 2011. e-Pub 2011. PMID: 28022749.
282. Wheler JJ, Janku F, Jackson T, Fu S, Sun M, Yang H, Naing A, Moulder SL, Tsimberidou AM, Hong DS, Falchook GS, Piha-Paul SA, Garcia-Manero G, Kurzrock R. Phase I study of anti-VEGF monoclonal antibody bevacizumab and HDAC inhibitor valproic acid in patients with advanced cancers. J Clin Oncol 29(15_suppl):2554, 2011. e-Pub 2011. PMID: 28022309.
283. Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Fu S, Piha-Paul SA, Naing A, Falchook GS, Janku F, Luthra R, Wen S, Kurzrock R. Personalized medicine in a phase I clinical trials program: The M. D. Anderson Cancer Center Initiative. J Clin Oncol 29(15_suppl):CRA2500, 2011. e-Pub 2011. PMID: 28023420.
284. El-Osta HE, Falchook GS, Tsimberidou AM, Hong DS, Naing A, Kim KB, Wen S, Janku F, Kurzrock R. Clinical characterstics and outcomes of patients with BRAF-mutant advanced cancer in a phase I clinic: The University of Texas M. D. Anderson Cancer Center experience. J Clin Oncol 29(15_suppl):10535, 2011. e-Pub 2011. PMID: 28021859.
285. Henary HA, Kurzrock R, Falchook GS, Naing A, Moulder SL, Wheler JJ, Tsimberidou AM, Durand J, Yang P, Johansen MJ, Newman R, Khan R, Patel U, Hong DS. Final results of a first-in-human phase I trial of PBI-05204, an inhibitor of AKT, FGF-2, NF-Kb, and p70S6K in advanced cancer patients. J Clin Oncol 29(15_suppl):3023, 2011. e-Pub 2011. PMID: 28022677.
286. Kurzrock R, Patnaik A, Rosenstein L, Fu S, Papadopoulos KP, Smith DA, Falchook GS, Chambers G, Gauvin JL, Naing A, Smith LS, Gonzalez T, Tsimberidou AM, Mays TA, Cox DS, Hong DS, DeMarini DJ, Le NT, Morris SR, Tolcher AW. Phase I dose-escalation of the oral MEK1/2 inhibitor GSK1120212 (GSK212) dosed in combination with the oral AKT inhibitor GSK2141795 (GSK795). J Clin Oncol 29(15_suppl):3085, 2011. e-Pub 2011. PMID: 28022515.
287. Garrido-Laguna I, Kurzrock R, Wheler JJ, Falchook GS, Phia-Paul SA, Fu S, Naing A, Hinojosa C, Mistry R, Scarmardo S, Culotta KS, Ekmekcioglu S, Wen S, Camacho LH, Ivy SP, Hong DS. Dual inhibition of VEGF pathway: Phase I trial bevacizumab and cediranib in advanced solid tumors. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
288. Kurzrock R, Naing A, Jones S, Bendell J, Falchook G. A phase 1, open-label, dose escalation, non-randomized study to assess the maximum tolerated dose, dose limiting toxicity, and pharmacokinetics of OPB-31121 in subjects with advanced solid tumors. AACR-NCI-EORTC 2011, 2011. e-Pub 2011.
289. Naing A, LoRusso P, Fu S, Hong DS, Anderson PM, Benjamin RS, Ludwig JA, Chen HX, Doyle L, Kurzrock R. Cixutumumab combined with temsirolimus is active in patients with refractory Ewing's sarcoma. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
290. Janku F, Garrido-Laguna I, Wheler JJ, Hong DS, Naing A, Falchook GS, Piha-Paul SA, Fu S, Moulder SL, Luthra R, Lee JJ, Tsimberidou AM, Kurzrock R. Screening for PIK3CA mutations, PTEN Loss and RAS/RAF mutations in early-phase protocols with P13K/mTor pathway inhibitors. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
291. Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Fu S, Phia-Paul SA, Naing A, Falchook GS, Jankuk F, Luthra R, Wen S, Kurzrock R. Personalized medicine in a Phase I clinical trials program: The MD Anderson Cancer Center Experience. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
292. El-Osta HE, Falchook GS, Tsimberidou AM, Hong DS, Naing A, Hinojosa C, Mistry R, Scamardo A, Culotta KS, Ekmekcioglu S, Wen S, Camacho LH, Ivy SP, Hong DS. Clinical characteristics and outcomes of patients with BRAF-mutant advanced cancer in a Phase I clinic: The MD Anderson Cancer Center Experience. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
293. Veasey-Rodrigues H, Naing A, Hong DS, Falchook GS, Fu S, Wheler JJ, Tsimberidou AM, Moulder SL, Janku F, Wen S, Fessahaye SN, Golden EC, Westerhold DI, Ewer M, Kurzrock R. The role of the electrocardiogram (ECG) in phase I drug development in patients with cancer: The MD Anderson Cancer Center Experience with 8,966 ECGs. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
294. Naing A, Aghajanian C, Kurzrock R, Kaye S, Banerji U. First results from a Phase 1 trial of AZD8055, a dual mTORC1 and mTORC2inhibitor. AACR-NCI-EORTC 2011, 2011. e-Pub 2011.
295. Naing A, Kurzrock R, Burger A, Gupta S, Lei X, Busaidy N, Hong D, Chen H, Doyle LA, Heilbrun LK, Rohren E, NG C, Chandhasin C, LoRusso P. Phase 1 Trials of Cixutumumab Combined with Temsirolimus in Patients with Advanced Cancer. Journal of Clinical Oncology, 2011. e-Pub 2011.
296. Falchook GS, Fu S, Amin HM, Piha-Paul SA, Tsimberidou AM, Hong DS, Wheler JJ, Naing A, , Klevesath MB, Mattiacci MR, Johne A, Nazeer S, Brichory F, Osterwalder B, Kurzrock R. A phase I dose-escalation study of EMD 1214063, an oral selective c-met inhibitor, in patients with advanced solid tumors. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
297. Sun M, Falchook GS, Wheler JJ, Hong DS, Piha-Paul SA, Tsimberidou AM, Naing A, Fu S, Moulder SL, Wen S, Mueller P, Kurzrock R. Association of VEGF single nucleotide polymorphisms (SNPs) with response and toxicity in patients treated with bevacizumab. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
298. Fu S, Hong DS, Naing A, Wheler JJ, Falchook GS, Wen S, Howard A, Barber D, Nates JL, Price KJ, Kurzrock R. Outcome analysis after the first admission to an intensive care unit in cancer patients enrolled into a Phase I clinical trials program: When is the optimal time to trigger code status discussion. J Clin Oncol 29, 2011. e-Pub 2011.
299. Banerji U, Aghajanian C, Raymond E, Kurzrock R, Blanco-Codesido M, Oelmann E, Grinsted L, Burke W, Kaye SB, Naing A. First results from a phase I trial of AZD8055, a dual mTORC1 and mTORC2 inhibitor. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
300. Wheler JJ, Janku F, Jackson T, Fu S, Sun M, Yang H, Naing A. Phase I Study of anti-VEGF monocional antibody bevacizumab and HDAC inhibitor valproic acid in patients with advanced cancers. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
301. Iskander NG, Tsimberidou AM, Letourneau K, Wen S, Wheler JJ, Hong DS, Naing A, Kurzrock R. Phase I clinical trial outcomes in 93 patients with brain metastases: The MD Anderson Cancer Center Experience. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
302. Henary HA, Kurzrock R, Falchook GS, Naing A, Moulder SL, Wheler JJ, Tsimberidou AM, Durand JB, Yang P, Johansen MJ, Newman R, Kahn R, Patel U, Hong DS. Final results of a first-in-human phase I trial of PBI-05204, an inhibitor of AKT, FGF-2, NF-kb and p70S6K in advanced cancer patients. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
303. Falchook G, Fu S, Amin H, Piha-Paul S, Hong D, Naing A. A Phase I Dose-escalation Study of EMD 1214063, an Oral Selective C-Met Inhibitor, in Patients with Advanced Solid Tumors. 2011 Stockholm Congress Poster Presentation, 2011. e-Pub 2011.
304. Kurzrock R, Patnaik A, Rosenstein L, Fu S, Papadopoulos KP, Smith DA, Falchook GS, Chambers G, Gauvin JLS, Naing A, Smith LS, Gonzalez T, Tsimberidou AM, Mays TA, Cox DS, Hong DS, MeMarini DJ, Le NT, Morris SR, Tolcher AW. Phase I dose escalation of the oral MEK1/MEK2 inhibitor GSK1120212 (GSK212) dosed in combination with the oral AKT inhibitor GSK2141795 (GSK795). ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
305. Janku F, Naing A, Falchook G, Hong D, Tsimberidou A, Fu S, Wheler J, Kurzrock R. PIK3CA mutations H1047R are associated with response to PIDK/AKT/mTOR signaling pathway inhibitors in early phase clinical trials. AACR-NCI-EORTC 2011, 2011. e-Pub 2011.
306. Stephen B, Wheler JJ, Tsimberidou AM, Wen S, Naing A, Hong DS, Falchook GS, Piha-Paul SA, Fu S, Janku F, Moulder SL, Kurzrock R. Survival of 1,181 patients in a Phase I clinic: The MD Anderson Cancer Center Experience. ASCO 2011 Annual Meeting, 2011. e-Pub 2011.
307. Fok J, Kurzrock R, Tsimberidou AM, Wen S, Naing A, Hong DS, et al. An umbrella protocol for histology-independent, phase I modular study based on EGFR mutation status: Using erlotinib alone or in combination with cetuximab, bortezomib, or dasatinib to overcome resistance. J Clin Oncol, 2011. e-Pub 2011.
308. Wheler JJ, Janku F, Jackson T, Fu S, Sun M, Yang H, Naing A, Moulder SL, Tsimberidou AM, Hong DS, Falchook GS, Piha-Paul SA, Garcia-Manero G, Kurzrock R. Phase I study of anti-VEGF monoclonal antibody bevacizumab and HDAC inhibitor valproic acid in patients with advanced cancers. J Clin Oncol 29, 2011. e-Pub 2011.
309. Stephen S, Naing A, Hong DS, Fu S, Wheler JJ, Moulder SL, Falchook GS, Tsimberidou AM, Piha-Paul SA, Kurzrock R. The use of complementary and alternative medicine in patients seen in phase I clinical trials program. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
310. Bustinza-Linares E, Falchook GS, Fu S, Naing A, Hong DS, Hu W, Moulder SL, Wheler JJ, Sood A, Kurzrock R. Phase 1 Trial of sequential azacitidine and valproic acid plus carboplatin in the treatment of patients with advanced malignancies. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
311. Jain RK, Lee J, Ng CS, Hong DS, Gong J, Naing A, Wheler JJ, Kurzrock R. Survival outcomes of patients who develop new lesions while participating on phase I oncology studies. 2010 ASCO Annual Meeting. e-Pub 2010.
312. Busaidy N, Kurzrock R, LoRusso P, Owens A D, Chen H X, Doyle L, Zhang J, Candhasin C, Naing A, . Hyperglycemia, hypertriglyceridemia, and hypercholesterolemia in a phase 1 trial of the combination of an mTOR inhibitor and IGF-1 receptor inhibitor. 2010 ASCO Annual Meeting(53681), 2010. e-Pub 2010.
313. Naing A, LoRusso P, Gupta S, Benjamin R S, Rohren E, Chen H X, Doyle L, Berry D A, Amin H M, Kurzrock R. Dual Inhibition of IGFR and mTOR Pathways. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
314. Fu S, Naing A, Moulder S L, Falchook G S, Culotta K S, Zhang Y, Madoff D C, Ng C S, Lim J, Kurzrock R. A Phase I study of hapatic arterial infusion of nab-paclitaxel in patients with predominant hepatic metastases. 2010 ASCO Annual Meeting. e-Pub 2010.
315. Garrido-Laguna I, Janku F, Tsimberidou A M, Wheler J J, Falchook G S, Fu S, Hong D D, Naing A, Piha-Paul S, Kurzrock R. Phosphatase and tensin homologue (PTEN) loss and response to phase i trials targeting PI3k/AKT/mTOR pathway in patients with advanced cancer. 2010 ASCO Annual Meeting. e-Pub 2010.
316. Janku F, Tsimberidou AM, Garrido-Laguna I, Hong DS, Naing A, Falchook GS, Wheler JJ, Fu S, Piha-Paul SA, Kurzrock R. PIK3CA, KRAS, and BRAF mutations in patients with advanced cancers treated with P13K/AKT/mTOR axis inhibitors. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
317. Wheler JJ, Tsimberidou AM, Wen S, Naing A, Hong DS, Falchook GS, Piha-Paul SA, Fu S, Moulder SL, Kurzrock R. Toxicity in 1,181 patients with advanced solid tumors treated in phase I clinical trials of predominantly targeted agents: The M. D. Anderson Cancer Center Experience. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
318. Falchook GS, Wheler JJ, Naing A, Hong DS, Moulder SL, Piha-Paul SA, Ng CS, Jackson E, Kurzrock R. A phase I study of bevacizumab in combination with sunitinib, sorafenib, and erlotinib plus cetuximab, and trastuzumab plus lapatinib. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
319. Subbiah V, Benjamin RS, Naing A, Trent JC, Hong DS, Pinnamaneni P, Garrido-Laguna I, Herzog CE, Kleinerman E, Kurzrock R. Novel phase I clinical trials in sarcoma patients: The M. D. Anderson Cancer Center experience. 2010 ASCO Annual Meeting. e-Pub 2010.
320. Fu S, Naing A, Kurzrock R, Moulder S, Falchook G. A Phase 1 Study of Hepatic Arterial Infusion of nab-Paclitaxel in Patients with Predominant Hepatic Metastases. 2010 ASCO Annual Meeting(51497), 2010. e-Pub 2010.
321. Hong DS, Koetz BS, Kurzrock R, Senzer NN, Hanekom W, Naing A, Wheler JJ, Mink J, Ren M, Neumanaitis JJ. Phase I dose-escalation study of E7080, a selective tyrosine kinase inhibitor, administered orally to patients with solid tumors. 2010 ASCO Annual Meeting, 2010. e-Pub 2010.
322. Tsimberidou AM, Vaklavas C, Wen S, Hong D, Wheler J, Ng CS, Naing A, Uehara C, Wolff R, Kurzrock R. Clinical outcomes and prognostic factors in 83 patients with pancreatic cancer treated in phase I clinical trials at M.D. Anderson Cancer Center. AACR 101st Annual Meeting in Washington, DC, 2010. e-Pub 2010.
323. Jain R, Lee J, Hong D, Gong J, Naing A, Wheler J, Kurzrock R. Change in tumor size by RECIST correlates lineraly with progression-free and overall survival in phase I studies. AACR 101st Annual Meeting in Washington DC, 2010. e-Pub 2010.
324. Naing A, Kurzrock R, Chen H, Hong D, Falchook GS, Doyle L, Lawhorn K, Burger A, Ng C, Hesham A, LoRusso P. Inhibitions of IGFR Pathway and mTOR Pathway. Poster Presentation for the 2009 AACR-NCI-EORTC International Conference on Molecular Target and Cancer Therapeutics, 2009. e-Pub 2009.
325. Jani R, Hong DS, Naing A, Wheler JJ, Lee J, Kurzrock R. Dose-response relationships in phase I trials-are patients treated at lower doses at a disadvantage?. American Society of Clinical Oncology, 2009. e-Pub 2009.
326. Bidyasar S, Kurzrock R, Falchook GS, Naing A, Wheler J, Durand J, Yang P, Johansen MJ, Newman RA, Khan R, Hong D. A first-in-human phase 1 trial of PBI-05204 (oleandrin), an inhibitor of AKt, FGF-2, NF-Kb, and p70S6K in advanced solid tumor patients. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
327. Naing A, LoRusso P, Kurzrock R. Phase 1 study of combining an IGFR inhibitor (IMC-A12) and mTOR inhibitor (CC1-779) to overcome tumor resistance to mTOR inhibitors. American Society of Clinical Oncology, 2009. e-Pub 2009.
328. Tsimberidou AM, Moulder S, Fu S, Wen S, Naing A, Bedikian AY, Daring S, Uehara C, Ng C, Wallace M, Camacho L, Kurzrock R. A Phase 1 study dose escalation clinical study of hepatic intraarterial cisplatin, combination systemic intravenous liposomal doxorubicin in patients advanced cancer dominant liver involvement. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
329. Falchook GS, Wheler J, Tannir NM, Naing A, Jackson E, Hong D, Lawhorn KN, Ng C, Amin H, Kurzrock R. Hypoxia-inducible factor-1a (HIF-la) modulation in combination with anti-angiogenic therapy. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
330. Moroney JW, Coleman RL, Hong DS, Wheler JJ, Ng C, Budurka DC, Falchook G, Naing A, Helgason T, Kurzrock R. A Phase 1 trial of liposomal doxorubicin (D), bevacizumab (A), and temsirolimus (T) in advanced malignancy. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
331. Davis DW, Liu W, Kurzrock R, Naing A, Wheler JJ, Ivy S, Hong D. Circulating tumor and endothelial cells as pharmacodynamic biomarkers in a phase 1 clinical trial of intravenous bevacizumab in combination with escalating doses of oral cediranib for patients with advanced malignancies. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
332. Wheler J, Tsimberidou AM, Moulder S, Cristofanilli M, Hong D, Naing A, Pathak R, Liu S, Feng L, Kurzrock R. Clinical outcomes of patients with breast cancer in a phase 1 clinic: The MD Anderson Cancer Center Experience. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
333. Jain R, Hong D, Naing A, Wheler JJ, Lee J, Kurzrock R. Dose-response relationships in phase 1 trials: Are patients treated at lower doses at a disadvantage?. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
334. Adjei AA, Cohen RB, Kurzrock R, Gordon GS, Hangauer D, Dyster L, Fetterly G, Barrientes S, Hong D, Naing A. Results of a Phase 1 trial of KX2-391, a novel non-ATP competitive substrate-pocket directed SRC inhibitor, in patients with advanced malignancies. 2009 ASCO Annual Meeting, 2009. e-Pub 2009.
335. Moroney JW, Coleman RL, Hong DS, Wheler JJ, Ng C, Bodurka DC, Falchook G, Naing A, Helgason T, Kurzrock R. A phase I trial of liposomal doxorubicin (D), bevacizumab (A), and temsirolimus (T) in advanced malignancy. American Society of Clinical Oncology, 2009. e-Pub 2009.
336. Vakalvas C, Tsimberidou AM, Moulder S, Ng C, Naing A, Daring S, Bedikian A, Uehara C, Kurzrock. A phase I trial study escalation clinical study of hepatic intraarterial cisplatin, combination systemic intravenous loposomal doxorubicim in patients with advanced cancer dominant liver involvement. American Society of Clinical Oncology, 2009. e-Pub 2009.
337. Falchook GS, Wheler JJ, Tannir NM, Naing A, Jackson E, Hong DS, Lawhorn KN, Ng C, Amin H, Kurzrock R. Hypoxia-inducible factor-1a (HIF-1a) modulation in combination with anti-angiogenic therapy. American Society of Clinical Oncology, 2009. e-Pub 2009.
338. Chintala L, Kurzrock R, Fu S, Naing A, Wheler JJ, Moulder SL, Newman R, Gagel R, Sebti S, Wright JJ, Hong DS. Phase I study of tipfarnib and sorafenib in patients with biopsiable advanced cancer (NCI protocol 7156). American Society of Clinical Oncology, 2008. e-Pub 2008.
339. Naing A, Reuben JM, Camacho LH, Verschraegen C, Fu S, Stephen S, Hong DS, Wheler JJ, Martinez M, Akinsanmi L, Kurzrock R. Phase I dose escalation study of sodium stibogluconate (SSG) Lenocta, a protein tyrosine phosphatase inhibitor, combined with interferon alpha for patients with solid tumors. 2008 ASCO Annual Meeting, 2008. e-Pub 2008.
340. Fu S, Chintala L, Madoff D, Hong DS, Naing A, Moulder SL, Wheler JJ, Ng CS, Lim J, Patterson M, Kurzrock R. A phase I study of hepatic arterial infusion of oxaliplatin plus intravenous fluorouracil, leucovorin, and bevacizumab in patients with predominant hepatic metastases. American Society of Clinical Oncology(3596):332, 2008. e-Pub 2008.
341. Guo Z, Wheler JJ, Naing A, Mani S, Goel S, Mulcahy M, Gamza F, Longley C, Buchbinder A, Kurzrock R. Clinical pharmacokinetics (PK) of EZN-2208, a novel anticancer agent, in patients (pts) with advanced malignancies: A phase I, first-in-human, dose-escalation study. American Society of Clinical Oncology, 2008. e-Pub 2008.
342. Aghajanian CA, Hamilin P, Gordon MS, Hong DS, Naing A, Younes A, Hannah A, Palladino MA, Spear MA, Kurzrock R. Phase I study of the novel proteasome inhibitor NPI-0052 in patients with lymphoma and solid tumors. American Society of Clinical Oncology, 2008. e-Pub 2008.
343. Falchook GS, Jackson EF, Wheler JJ, Moulder SL, Hong DS, Naing A, Tannir NM, Lawhorn KN, Ng CS, Kurzrock R. Anti-angiogenic therapy in combination with hypoxia-inducible factor-1 alpha (HIF-1alpha) modulation. Proceedings of the American Society of Clinical Oncology. 2008 ASCO Annual Meeting, 2008. e-Pub 2008.
344. Naing A, Pallmer J, Tsai NC, Kogut N, Popplewell L, Krishnan A, Nakamura R, Forman SJ, Nademanee A. Impact of Rituxan on Outcomes Following Autologous Transplantation for Mantle Cell Lymphoma. American Society of Clinical Oncology, 2006. e-Pub 2006.
345. Naing A, Nakamura R, Rodriguez R, Palmer J, Stein A, Chang K, Slovak ML, Bhatia R, Kirschbaum M, Forman SJ, O'Donnell MR. Reduced-intensity allogeneic hematopoietic stem cell transplantation for myelodyplastic syndrome. American Society for Blood & Marrow Transplantation, 2006. e-Pub 2006.
346. Naing A, Cheng F, Wang H, Horna P, Suarez I, Brayer J, List AF, Sotomayor EM. Lenalidomide (CC5013), a Thalidomide Analogue with Immunomodulatory Properties, Significantly Enhances the Function of Antigen-Presenting Cells (APCs). Joint Cancer Conference Oncology Young Investigators Forum, 2005. e-Pub 2005.
347. Wang H, Cheng F, Naing A, Atadja AP, Bhalla K, Sotomayor EM. Histone deacetylase (HDAC) inhibitor LAQ842 is a potent inducer of inflammatory antigen-presenting cells (APCs) that effectively prime naïve antigen-specific t-cells and restore the responsiveness of anergic t-cells from tumor bearing hosts. American Society of Hematology, 2003. e-Pub 2003.

Book Chapters

1. Naing, Aung, Mills Gordon B, Meric-Bernstam, Funda. Combination Therapies Targeting the PI3K/AKT/mTOR Pathways. In: PI3K-mTOR in Cancer and Cancer Therapy. Springer, 2016.
2. Habra, Amir M, Naing, Aung. Adrenocortical Carcinoma. In: Handbook of Targeted Cancer Therapy, 2014.

Books (edited and written)

1. Naing A, Hajjar J. Immunotherapy. Ed(s) 3. Springer, 2020.
2. Naing A, Hajjar J. Immunotherapy. Ed(s) 2. Springer, 2018.

Letters to the Editor

1. Naing A, Aaron J, Kurzrock R. Juice Plus or Toxicity Plus. Am J Med 123 (1): e1-2, 2010.