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Etavopivat for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Forma Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Summary
This trial is testing a medication called etavopivat to see if it can help treat anemia in adults with certain types of Myelodysplastic Syndromes (MDS). These patients have a form of anemia that may not respond well to usual treatments. Etavopivat works by improving the function of red blood cells and is being developed for the treatment of sickle cell disease and other hemoglobin disorders.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4(first 6 participants), 16, 24, and 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4(first 6 participants), 16, 24, and 48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The hematologic improvement based on an erythroid response (HI -E) ≥ 8 weeks duration in patients with MDS after 16 weeks of etavopivat treatment
Secondary study objectives
Blood Transfusion
Change from baseline in mean daily dose of iron chelation therapy
Body Weight Changes
+10 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs), which boost red blood cell production by stimulating the bone marrow, and thrombopoietin receptor agonists, which increase platelet production to reduce bleeding risks. DNA hypomethylating agents, such as azacitidine, work by reversing abnormal DNA methylation patterns, thereby restoring normal function to genes involved in blood cell production.
The investigational drug etavopivat (FT-4202), a pyruvate kinase-R (PKR) activator, aims to enhance red blood cell metabolism and improve their survival and function. These treatments are crucial for MDS patients as they address the underlying issues of ineffective hematopoiesis, thereby improving blood counts and reducing the need for transfusions.
Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS).Anemia as the Main Manifestation of Myelodysplastic Syndromes.Strategic Role of Nuclear Inositide Signalling in Myelodysplastic Syndromes Therapy.
Recent advances in the treatment of lower-risk non-del(5q) myelodysplastic syndromes (MDS).Anemia as the Main Manifestation of Myelodysplastic Syndromes.Strategic Role of Nuclear Inositide Signalling in Myelodysplastic Syndromes Therapy.
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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
1,546 Previous Clinical Trials
2,443,892 Total Patients Enrolled
Anne Renteria, MDStudy DirectorForma Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My MDS is linked to a specific genetic change and has not been caused by previous cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Etavopivat 400 mg QD daily
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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