Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Recruiting
Forma Therapeutics, Inc.
Phase 1/Phase 2
2016-04-01
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib)
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 (olutasidenib) (single agent) and FT-2102 (olutasidenib) +
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 (olutasidenib) activity as well as
combination activity with azacitidine or cytarabine. Following the completion of the relevant
Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different
cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102
(olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
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