Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Forma Therapeutics, Inc.
Updated on 30 July 2021
myeloid leukemia
cytarabine
leukemia
azacitidine
aml/mds

Summary

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.

Details
Condition Bone marrow disorder, Preleukemia, Acute myeloid leukemia, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), myelodysplastic syndromes, myelodysplastic syndrome (mds), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment cytarabine, Azacitidine, FT-2102, FT-2102 (olutasidenib)
Clinical Study IdentifierNCT02719574
SponsorForma Therapeutics, Inc.
Last Modified on30 July 2021

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