EUCTR2017-001051-32-IT
Active, not recruiting
Phase 1
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. - Study to evaluate FT-2102 as a single agent or in combination with Azacitidine or Cytarabine in pati
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
- Sponsor
- FORMA THERAPEUTICS, INC.
- Enrollment
- 529
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Pathologically proven AML (except acute promyelocytic leukemia with the
- •t(15;17\) translocation) or intermediate, high risk or very high risk MDS as
- •defined by the World Health Organization (WHO) criteria or Revised
- •International Prognostic Scoring System (IPSS\-R) harboring IDH1\-R132
- •mutations, and one of the following based on enrollment stage or treatment
- •a.Single Agent Phase 1 Cohorts including Dose\-Escalation/ Dose\-Expansion:
- •AML/MDS either R/R to standard therapy, or for whom standard treatments
- •are contra\-indicated b.Combination (FT\-2102 \+ azacitidine) Phase 1 Dose\-
- •Escalation/ Dose\-Expansion (patients must meet one of the following):
- •i. Patients with AML that is either R/R to standard therapy, or for whom
Exclusion Criteria
- •1\.Phase 1 Single Agent Dose\-escalation/Dose\-expansion Cohorts and Phase 2
- •Cohorts 1, 4, 5, 7 and 8 only: Patients who have been treated with an IDH1
- •targeted therapy are excluded
- •2\.Phase 2 Single Agent Cohorts 1\-3 and 7 only: Patients with IDH2 mutation
- •detection at baseline or history of IDH2m inhibitor treatment are excluded
- •3\.History of prior malignancy unless disease\-free for \= 12 months or
- •considered surgically cured; patients with nonmelanoma skin cancers or with
- •carcinomas in situ are eligible regardless of the time from diagnosis (including
- •concomitant diagnoses)
- •4\.Patients with symptomatic central nervous system (CNS) metastases or
Outcomes
Primary Outcomes
Not specified
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