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.
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat
newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring
an IDH1 mutation.
The main question the study aims to answer is whether the combination of olutasidenib and
temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat
newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring
an IDH1 mutation.
The main question the study aims to answer is whether the combination of olutasidenib and
temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
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