This study is in progress, not accepting new patients

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

a study on Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study start
estimated completion
Principal Investigator
by Gary Schiller

Description

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.

Official Title

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

Keywords

Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, AML, MDS, IDH1, IDH, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Myelodysplastic Syndromes, Cytarabine, Azacitidine, FT-2102 (olutasidenib), PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine, PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.
  • Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  • Good performance status
  • Good kidney and liver function

You CAN'T join if...

  • Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  • Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Locations

  • UCLA Medical Center
    Los Angeles California 90024 United States
  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States

Lead Scientist at UCLA

  • Gary Schiller
    Professor-in-Residence, Medicine. Authored (or co-authored) 146 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Forma Therapeutics, Inc.
ID
NCT02719574
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 336 people participating
Last Updated