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Status: RecruitingPhase: Phase 1Diagnosis: Leukemia/MDSNCT ID: NCT01915498
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-371
Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD, and clinical activity evaluation of orally administered AG-221 in subjects with advanced hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical activity of AG-221 in select populations.
Conducting Institutions: Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute
Overall PI: Amir Fathi, M.D.,
Massachusetts General Hospital
Site-responsible Investigators: Richard Stone, MD,
Dana-Farber Cancer Institute
Contacts: Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,