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James M. Cleary, MD, PhD

Medical Oncology

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James M. Cleary, MD, PhD


  • Director, Clinical Research, Division of Gastrointestinal Oncology
  • Senior Physician
  • Assistant Professor, Harvard Medical School


Clinical Interests

  • Gastrointestinal malignancies
  • Phase 1 clinical trials

Contact Information

  • Appointments617-632-5929
  • Office Phone Number617-632-6073
  • Fax617-632-5370

Board Certification:

  • Internal Medicine, 2006
  • Medical Oncology, 2008


  • Dana-Farber Cancer Institute, Medical Oncology


  • Massachusetts General Hospital, Internal Medicine

Medical School:

  • Albert Einstein Medical School


Early Drug Development, Gastrointestinal Malignancies, Translational Research

My career is focused on phase 1 and proof-of-mechanism clinical trials that are testing new targeted therapies and novel therapeutic strategies. While I conduct trials appropriate for a broad range of solid tumors, I am particularly interested in new drug development for gastrointestinal malignancies. Currently, I am developing several protocols appropriate for specific molecularly defined patient cohorts, including those whose tumors are dependent on EGFR, mutant K-Ras and mutant B-Raf, respectively. I also interact with Dana-Farber translational researchers to understand and develop predictors of sensitivity and resistance to targeted agents that can be incorporated into patient selection for trials.

Cleary JM, Sadow PM, Randolph GW, Palmer EL, Lynch TP, Nikiforov YE, Wirth LJ. Neoadjuvant Treatment of Unresectable Medullary Thyroid Cancer with Sunitinib. Journal of Clinical Oncology; In press

Cleary JM and Shapiro GI. Development of Phosphoinositide 3-kinase pathway inhibitors for advanced cancer. Current Oncol Rep 2010; 12:87-94

Cleary JM, Tanabe KT, Lauwers GY, Zhu AX. Hepatic toxicities associated with the use of preoperative systemic therapy in patients with metastatic colorectal adenocarcinoma to the liver. The Oncologist 2009; 14:1095-1105.

Cleary JM and Chabner BA. Angiogenesis inhibitors. In: Brunton L, Lazo J, Parker K, editors. Goodman and Gilmans The pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill. In press


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