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Gerald S. Falchook, M.D.

Present Title & Affiliation

Primary Appointment

Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX

Dual/Joint/Adjunct Appointment

Associate Member of the Graduate Faculty, Graduate School of Biomedical Sciences, The University of Texas MD Anderson Cancer Center, Houston, TX

Research Interests

  • Phase I clinical trials
  • Drug development
  • Angiogenesis
  • Targeted therapy

Clinical Interests

Targeted therapy

Office Address

The University of Texas MD Anderson Cancer Center
1515 Holcombe Boulevard
Unit Number: Unit 455
Houston, TX 77030
Room Number: FC8.3022
Email: gfalchoo@mdanderson.org

Education & Training

Degree-Granting Education

2009 University of Texas Health Science Center Graduate School of Biomedical Sciences, Houston, TX, MS, Cancer Biology
2001 Louisiana State University School of Medicine, New Orleans, LA, MD, Medicine
1997 Rice University, Houston, TX, BA, Biochemistry, Biology, History

Postgraduate Training

11/2007-12/2007 Externship, National Cancer Institute, Cancer Therapy Evaluation Program (NCI-CTEP), Bethesda, MD
7/2005-6/2008 Clinical Fellowship, Medical Oncology and Hematology, The University of Texas MD Anderson Cancer Center, Houston, TX
6/2001-6/2004 Clinical Residency, Internal Medicine, Baylor College of Medicine, Houston, TX

Board Certifications

2008 Medical Oncology
2004 American Board of Internal Medicine

Experience/Service

Administrative Appointments/Responsibilities

Associate Medical Director, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, Clinical Translational Research Center (CTRC), Houston, TX, 9/2012-present
Co-director, ICT Clinical Studies Meeting, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, 9/2011-present

Other Appointments/Responsibilities

Inpatient Liaison, The University of Texas MD Anderson Cancer Center, Houston, TX, 10/2008-present

Institutional Committee Activities

Member, Faculty Senate Research Affairs Committee, 7/2011-present
Representative, Faculty Senate, 9/2009-present
Member, Clinical Research Committee (CRC) 2, 2009-present
Member, Scientific Publications Advisory Board, 2006-present

Selected Publications

Peer-Reviewed Original Research Articles

1. Henary H, Hong DS, Falchook GS, Tsimberidou A, George GC, Sijin JW, 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, doi: 10.1093/annonc/mdt115, 8/2013. PMID: 23576709.
2. Hong DS, George GC, Iwuanyanwu EC, Tavana B, Falchook GS, Piha-Paul SA, Wheler JJ, Mistry RH, Lei X, Kurzrock R. Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy. J Cancer Res Clin Oncol 139(6):963-70, doi: 10.1007/s00432-013-1404-6, 6/2013. e-Pub 3/2013. PMID: 23455881.
3. Ganesan P, Piha-Paul S, Naing A, Falchook G, 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. Invest New Drugs. e-Pub 6/2013. PMID: 23756764.
4. Said R, Hong DS, Warneke CL, Lee J, Wheler JJ, Janku F, Naing A, Falchook GS, Fu S, Piha-Paul S, Tsimberidou AM, Kurzrock R. P53 mutations in advanced cancers: clincial characteristics, outcomes, and corrleation between progressino-free survival and bevacizumab-containing therapy. Oncotarget 4(5):705-14, 5/2013. PMID: 23756764.
5. Wheler JJ, Falchook GS, Tsimberidou AM, Hong DS, Naing A, Piha-Paul S, Chen S, Heymach J, Fu S, Stephen B, Fok J, 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, 5/2013. PMID: 23800712.
6. 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. e-Pub 4/2013. PMID: 23609829.
7. 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 24(3):838-42, 10.1093/annonc/mds524, 3/2013. e-Pub 11/2012. PMID: 23139256.
8. Falchook GS, Rady P, Hymes S, Nguyen HP, Tyring SK, Prieto VG, Hong DS, Kurzrock R. Merkel cell polyomavirus and HPV-17 associated with cutaneous squamous cell carcinoma arising in a melanoma patient treated with the BRAF inhibitor dabrafenib. JAMA Dermatol 149(3):322-6, doi: 10.1001/jamadermatol.2013.2023, 3/2013. PMID: 23552670.
9. Falchook GS, Trent JC, Heinrich MC, Beadling C, Patterson J, Bastida CC, Blackman SC, Kurzrock R. BRAF mutant gastrointestinal stromal tumor: first report of regression with BRAF inhibitor dabrafenib (GSK2118436) and whole exomic sequencing for analysis of acquired resistance. Oncotarget 4(2):310-5, 2/2013. PMCID: PMCPMC3712576.
10. Curry JL, Falchook GS, Hwu WJ, Torres-Cabala CA, Duvic M, Tetzlaff MT, Prieto VG. Changes in tumor morphology and cyclin-dependent kinase inhibitor expression in metastatic melanoma treated with selective second-generation BRAF inhibitor. Am J Dermatopathol 35(1):125-8, doi: 10.1097/DAD.0b013e318263f232, 2/2013. e-Pub 8/2012. PMID: 22878367.
11. 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 71(2):389-97, doi: 10.1007/s00280-012-2014-8, 2/2013. e-Pub 11/2012. PMID: 23143207.
12. Tsimberidou AM, Leick M, 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 71(2):389-97, doi: 10.1007/s00280-012-2014-8, 2/2013. e-Pub 11/2012. PMID: 23143207.
13. Falchook GS, Janku F, Tsao AS, Bastida CC, Stewart DJ, Kurzrock R. Non-small-cell lung cancer wtih HER2 exon 20 mutation: regression with dual HER2 inhibition and anti-VEGF combination treatment. J Thorac Oncol 8(2):e19-20, 10.1097/JTO.0b013e31827ce38e, 2/2013. e-Pub 2/2013. PMCID: PMCPMC3551245.
14. 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):118-127, 1/2013. e-Pub 1/2013. PMCID: PMC3702212.
15. Janku F, Wheler JJ, Naing A, Falchook GS, Hong DS, Stepanek V, 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, DOI: 10.1158/0008-5472.CAN-12-1726, 1/2013. e-Pub 10/2012. PMCID: PMCPMC3537862.
16. 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 I trials. Oncotarget 4(1):156-65, 1/2013. e-Pub 1/2013. PMID: 23391555.
17. 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, doi: 10.1016/j.clcc.2012.02.001, 12/2012. e-Pub 4/2012. PMID: 22537607.
18. Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, Hamid O, Schuchter L, Cebon J, Ibrahim N, Kudchadkar R, Burris HA, Falchook G, Algazi A, Lewis K, Long GV, Puzanov I, Lebowitz P, Singh A, Little S, Sun P, AllredA, Ouellet D, Kim KB, Patel K, Weber J. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. New England Journal of Medicine 367(18):1694-703, DOI: 10.1056/NEJM0a1210093, 11/2012. PMCID: PMCPMC3549295.
19. 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 anticancer drug development: the MD Anderson Cancer Center experience with 8518 ECGs. Ann Oncol 23(11):2960-3, doi:10.1093/annonc/mds130, 11/2012. e-Pub 6/2012. PMID: 22745218.
20. Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul SA, Naing A, Janku F, Luthra R, Ye Y, Wen S, Berry DA, Kurzrock R. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res 18(22):6373-83, 10.1158/1078-0432.CCR-12-1627, 11/2012. e-Pub 9/2012. PMID: 22966018.
21. 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). e-Pub 11/2012. PMID: 23248156.
22. Moroney J, Fu S, Moulder SL, Falchook GS, Helgason T, Levenback CF, Hong DS, Naing A, Wheler JJ, Kurzrock R. Phase I study of the antiangiogenic antibody bevacizumab and the mTOR / hypoxia-inducible factor inhibitor temsirolimus combined with liposomal doxorubicin: tolerance and biological activity. Clin Cancer Res 18(20):5796-5805, 10.1158/1078-0432.CCR-12-1158, 10/2012. e-Pub 8/2012. PMID: 22927482.
23. 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 M. D. Anderson Cancer Center experience. Ann Oncol 23(8):1963-67, 9/2012. e-Pub 2/2012. PMID: 22377564.
24. Hong DS, Bowles DW, Falchook GS, Messersmith WA, George GC, O'Bryant CL, Vo AC, Klucher K, Herbst RS, Eckhardt SG, Peterson S, Hausman DF, Kurzrock R, Jimeno A. A multicenter phase I trial of PX-866, an oral irreversible phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors. Clin Cancer Res 18(15):4173-82, 8/2012. e-Pub 6/2012. PMID: 22693357.
25. Falchook GS, Lewis KD, Infante JR, Gordon MS, Vogelzang NJ, Demarini DJ, Sun P, Moy C, Szabo SA, Roadcap LT, Peddareddigari VG, Lebowitz PF, Le NT, Burris HA, Messersmith WA, O'Dwyer PJ, Kim KB, Flaherty K, Bendell JC, Gonzalez R, Kurzrock R, Fecher LA. Activity of the oral MEK inhibitor trametinib in patients with advanced melanoma: a phase 1 dose-escalation trial. Lancet Oncol 13(8):782-789, 8/2012. e-Pub 7/2012. PMID: 22805292.
26. 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, 8/2012. e-Pub 7/2012. PMID: 22778314.
27. Infante JR, Fecher LA, Falchook GS, Nallapareddy S, Gordon MS, Becerra C, Demarini DJ, Cox DS, Xu Y, Morris SR, Peddareddigari VG, Le NT, Hart L, Bendell JC, Eckhardt G, Kurzrock R, Flaherty K, Burris HA, Messersmith WA. Safety, pharmacokinetic, pharmacodynamic, and efficacy data for the oral MEK inhibitor trametinib: a phase I dose-escalation trial. Lancet Oncol 13(8):773-781, 8/2012. e-Pub 7/2012. PMID: 22805291.
28. 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, 5/2012. e-Pub 12/2011. PMID: 22205203.
29. Falchook GS, Long GV, Kurzrock R, Kim KB, Arkenau TH, Brown MP, Hamid O, Infante JR, Millward M, Pavlick AC, O'Day SJ, Blackman SC, Curtis CM, Lebowitz P, Ma B, Ouellet D, Kefford RF. Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase I dose-escalation trial. The Lancet 379(9829), doi: 10.1016/S0140-6736(12)60398-5, 05/19/2012. e-Pub 5/2012. PMID: 22608338.
30. Wheler JJ, Tsimberidou AM, Hong DS, Naing A, Falchook GS, Sarina PP, Fu S, Moulder SL, 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, 5/2012. e-Pub 3/2012. PMID: 22452943.
31. Hong DS, Vence L, Falchook G, Radvanyi LG, Liu C, Goodman V, Legos JJ, Blackman S, Scarmadio A, Kurzrock R, Lizee G, Hwu P. BRAF(V600) inhibitor GSK2118436 targeted inhibition of mutant BRAF in cancer patients does not impair overall immune competency. Clin Cancer Res 18(8):2326-35, 4/2012. e-Pub 2/2012. PMID: 22355009.
32. 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):777-782, 3/2012. e-Pub 1/2012. PMID: 22271473.
33. 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, 3/2012. e-Pub 8/2011. PMID: 21823111.
34. 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 5/2012. PMCID: PMC3364990.
35. Fu S, Hong DS, Naing A, Wheler J, Falchook G, Wen S, Howard A, Barber D, Nates J, Price K, Kurzrock R. Outcome analyses 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, 9/2011. e-Pub 8/2011. PMID: 21844494.
36. Curry JL, Falchook GS, Torres-Cabala CA, Tetzlaff MT, Prieto VG. Resistant mechanisms to BRAF inhibitor PLX4032 in melanoma. Expert Rev Dermatol 6(4):355-357, 8/2011.
37. 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, 7/2011. e-Pub 5/2011. PMID: 21571911.
38. 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 inhibitors. Mol Cancer Ther 10(3):558-65, 3/2011. e-Pub 1/2011. PMCID: PMC3072168.
39. 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 10/2011. PMCID: PMC3198456.
40. 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 8/2011. PMID: 21859821.
41. 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 7/2011. PMCID: PMC3146490.
42. 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, 8/2010. e-Pub 6/2010. PMID: 20525754.
43. 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 M. D. Anderson Cancer Center experience. Gynecol Oncol 117(3):467-72, 6/2010. e-Pub 3/2010. PMCID: PMC2882061.
44. Hayes TG, Falchook GS, Varadhachary A. Phase IB trial of oral talactoferrin in the treatment of patients with metastatic solid tumors. Invest New Drugs 28(2):156-62, 4/2010. e-Pub 2/2009. PMID: 19238327.
45. Falchook GS, Vega F, Dang NH, Samaniego F, Rodriguez MA, Champlin RE, Hosing C, Verstovsek S, Pro B. Hepatosplenic gamma-delta T-cell lymphoma: clinicopathological features and treatment. Ann Oncol 20(6):1080-5, 6/2009. e-Pub 2/2009. PMID: 19237479.
46. Falchook GS, Varadhachary GR, Wolff RA. Clinicopathologic features and treatment strategies for patients with pancreatic adenocarcinoma and ovarian metastases. Gynecol Oncol 108(3):515-9, 2008. PMID: 18164378.

Last updated: 8/28/2013