A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS) (NCT05568225) | Clinical Trial Compass
TerminatedPhase 2
A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS)
Stopped: Futility assessment concluded low likelihood of the trial showing meaningful patient benefit.
United States17 participantsStarted 2022-11-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient has provided documented informed consent; the informed consent form (ICF) must be reviewed and signed by each patient prior to any study-related assessments/procedures being conducted.
✓. Age ≥ 18 years at time of first dose.
✓. Patients, if female and of childbearing potential, must agree to use acceptable methods of contraception and agree not to donate ova from study start to 90 days after the last dose of study drug, and who if male are willing to use acceptable methods of contraception and agree not to donate sperm, from study start to 90 days after the last dose of study drug.
✓. Documented diagnosis of idiopathic/de novo MDS according to World Health Organization (WHO) classification that meets the IPSS-R classification of very low, low, or intermediate risk disease, and:
✓. Anemia defined as:
✓. Serum erythropoietin level \> 200 U/L, OR, if ≤ 200 U/L, subject is non-responsive, refractory, or intolerant to erythropoiesis-stimulating agents, or erythropoiesis-stimulating agents are contraindicated or unavailable.
✓. ECOG performance status of ≤ 2
✓. Subject is non-responsive, refractory, or intolerant to luspatercept, or luspatercept is contraindicated or not indicated.
Exclusion criteria
✕. MDS associated with del 5q cytogenetic abnormality and known TP53 abnormality
✕. Therapy-associated MDS (eg. t-MDS) that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases
What they're measuring
1
Percentage of Participants With Hematologic Improvement- Erythroid (HI-E) Response for >=8 Weeks Within 24 Weeks of Etavopivat Treatment
✕. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
✕. Absolute neutrophil count \< 500/µL (0.5 x 10\^9/L)
✕. Platelet count \< 50,000/µL (50 x 10\^9/L) without transfusion support within 2 weeks