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Etavopivat for Myelodysplastic Syndrome

Phase 2
Recruiting
Research Sponsored by Forma Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at time of first dose
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4(first 6 participants), 16, 24, and 48 weeks
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a new drug for treating anemia in adults with MDS.

Who is the study for?
Adults with low to intermediate risk Myelodysplastic Syndromes (MDS) and anemia can join this trial. They must have less than 5% bone marrow blasts, not be pregnant or breastfeeding, agree to use contraception, and cannot have had certain treatments like luspatercept recently. People with severe infections, other cancers within the last two years, significant heart or kidney disease are excluded.Check my eligibility
What is being tested?
The trial is testing Etavopivat's safety and effectiveness in treating anemia for MDS patients who are at very low to intermediate risk. It will include adults who haven't responded well to other treatments or for whom those treatments aren't suitable.See study design
What are the potential side effects?
While specific side effects of Etavopivat aren't listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, potential liver enzyme changes, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4(first 6 participants), 16, 24, and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4(first 6 participants), 16, 24, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The hematologic improvement based on an erythroid response (HI -E) ≥ 8 weeks duration in patients with MDS after 16 weeks of etavopivat treatment
Secondary outcome measures
Blood Transfusion
Change from baseline in mean daily dose of iron chelation therapy
Body Weight Changes
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Etavopivat 400 mg QD dailyExperimental Treatment1 Intervention
Non-transfusion dependent (NTD), Low transfusion burden (LTB) , and High transfusion burden (HTB) patients

Find a Location

Who is running the clinical trial?

Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
1,204 Total Patients Enrolled
Novo Nordisk A/SLead Sponsor
1,508 Previous Clinical Trials
2,387,184 Total Patients Enrolled
Anne Renteria, MDStudy DirectorForma Therapeutics

Media Library

Etavopivat (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05568225 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Etavopivat 400 mg QD daily
Myelodysplastic Syndrome Clinical Trial 2023: Etavopivat Highlights & Side Effects. Trial Name: NCT05568225 — Phase 2
Etavopivat (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05568225 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study currently have openings for participants?

"Per clinicaltrials.gov, the trial is recruiting participants and was first listed on November 22nd 2022 with its most recent edit occurring December 13th of that same year."

Answered by AI

How detrimental can the daily ingestion of Etavopivat 400mg be to individuals?

"Despite being a Phase 2 trial, meaning efficacy data is limited, there are indications that etavopivat 400 mg QD daily has some degree of safety; thus earning it an assessment score of 2."

Answered by AI

How many participants are being accepted into this research initiative?

"Affirmative, this clinical trial is currently seeking participants. According to the information on clinicialtrials.gov, it was originally posted on November 22nd 2022 and last updated December 13th 2022. 45 candidates are needed from two different sites for enrolment in the study."

Answered by AI
~20 spots leftby May 2025