A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Forma Therapeutics, Inc.
- Study ID
- NCT05568225
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Very Low Risk, Low Risk, or Intermediate Risk MDS Per IPSS-R
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Etavopivat — DRUG400 mg once daily
Study Details
The purpose of this study is to evaluate the safety and efficacy of etavopivat (FT-4202) for the treatment of anemia in adult patients with very low risk, low risk, or intermediate risk MDS.
Key Dates
- Start date
- Nov 15, 2022
- Status verified
- Oct 2025
- Primary completion
- Jul 15, 2024
- Completion
- Jul 15, 2024
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Etavopivat 400 mg QD dailyNon-transfusion dependent (NTD), Low transfusion burden (LTB) , and High transfusion burden (HTB) patients
Primary Outcome Measure
Percentage of Participants With Hematologic Improvement- Erythroid (HI-E) Response for >=8 Weeks Within 24 Weeks of Etavopivat Treatment [ Time Frame: From Baseline to Week 24 ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | - |
| Ocala Oncology | Ocala | Florida | 34474 | - |
| Cedars-Sinai Medical Center | Plainsboro | New Jersey | 08536 | - |
| Northwell Health | Plainsboro | New Jersey | 08536 | - |
| Northwestern Memorial Hospital | Plainsboro | New Jersey | 08536 | - |
| The Ohio State University Medical Center | Plainsboro | New Jersey | 08536 | - |
| Columbia University Irving Medical Center | New York | New York | 10032 | - |
| NYU Langone Health | New York | New York | 10016 | - |
Related coverage on Hipa.ai
- Etavopivat Phase 2 for MDS Anemia: 50% HI-E Response in Low Transfusion BurdenEtavopivat · Oct 22, 2025 · ClinicalTrials.gov