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A Phase 1 / 2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation


Active: Yes
Cancer Type: Leukemia
Myelodysplastic Syndromes (MDS)
NCT ID: NCT02719574
Trial Phases: Phase I
Phase II
Protocol IDs: 2102-HEM-101 (primary)
NCI-2016-00637
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Forma Therapeutics, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT02719574

Summary

This Phase 1 / 2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 activity as well as combination activity with azacitidine or cytarabine. Following the completion of Phase 1, Phase 2 will begin enrollment. Patients will be enrolled across 6 different cohorts, examining the effect of FT-2102 (as a single agent) and FT-2102 + azacitidine (combination) on various AML / MDS disease states.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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