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TGFβ receptor inhibitor
Vactosertib for Myeloproliferative Disorder
Phase 2
Recruiting
Led By Joseph M Scandura, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ESA refractoriness defined by lack of erythroid hematologic improvement to ESA:27
Proven ESA unsuitability is defined by history of any of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through 40 weeks
Awards & highlights
Study Summary
This trial will test if a TGFβ receptor inhibitor can help treat anemic patients with myeloproliferative neoplasms by abnormal TGFβ signals. Up to 37 patients will receive the study drug.
Who is the study for?
This trial is for anemic patients with myeloproliferative neoplasms who meet specific blood criteria, have high erythropoietin levels, and are unsuitable or unresponsive to standard anemia treatments. It's not for those with recent strokes/TIAs, breastfeeding women, or anyone with conditions that make the study unsafe for them.Check my eligibility
What is being tested?
The trial tests Vactosertib, a drug targeting TGFβ signals thought to disrupt blood cell formation in these disorders. Patients receive personalized doses within a safe range based on effectiveness and side effects. Up to 37 people will participate.See study design
What are the potential side effects?
Specific side effects of Vactosertib aren't listed here but may include typical reactions related to altering TGFβ pathways such as issues with wound healing, immune system changes, or gastrointestinal symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My anemia did not improve with ESA treatment.
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I have had issues with erythropoiesis-stimulating agents.
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My myelofibrosis is classified as intermediate or high-risk.
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My hemoglobin did not increase by more than 1.5 g/dL after 6 weeks of ESA therapy.
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My anemia has worsened despite higher doses of ESA.
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I have anemia or needed a blood transfusion recently due to low hemoglobin.
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I cannot use or did not respond to ESA therapy for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through 40 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through 40 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Change in hemoglobin values while taking vactosertib
Change in spleen size while taking vactosertib
+3 moreSecondary outcome measures
Change in MPN driver mutation ratios in patients taking vactosertib
Change in Molecular activity of vactosertib
Histologic change in the bone marrow
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment1 Intervention
Vactosertib intra-patient dose finding cohort.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,317,068 Total Patients Enrolled
Joseph M Scandura, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My anemia did not improve with ESA treatment.I have had issues with erythropoiesis-stimulating agents.My myelofibrosis is classified as intermediate or high-risk.My doctor thinks ESA treatments are not safe for me due to side effects.My hemoglobin did not increase by more than 1.5 g/dL after 6 weeks of ESA therapy.I am not breastfeeding nor plan to during the study or for 30 days after the last dose.My condition matches the WHO 2016 criteria for a specific blood disorder.My heart health is good.My anemia has worsened despite higher doses of ESA.I have anemia or needed a blood transfusion recently due to low hemoglobin.I have not had a stroke or TIA in the last year.I still need regular blood transfusions and haven't needed 4 fewer units than before over 8 weeks.I cannot use or did not respond to ESA therapy for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the enrollment capacity for this experiment?
"Affirmative. Perusal of the information hosted on clinicaltrials.gov discloses that this medical trial, first posted 11/22/2019, is currently recruiting participants. 37 individuals from 1 location are needed to complete the study's recruitment phase."
Answered by AI
Have any similar studies ever been conducted prior to this one?
"Since 2018, the pharmaceutical company MedPacto Inc. has been researching Vactosertib - first in a 62-patient clinical trial which granted it Phase 1 & 2 approval. Currently there are 12 ongoing trials for this drug spanning 3 cities and 2 nations."
Answered by AI
Has the FDA sanctioned Vactosertib for therapeutic use?
"Our team at Power has assigned Vactosertib a score of 2 on its safety scale due to the existence of Phase 2 trial data that suggest some level of security, but no efficacy evidence."
Answered by AI
Are there still vacancies open for participants in this research project?
"Clinicaltrials.gov data confirms that this research project is currently accepting participants, having been posted on November 22nd 2019 and last updated December 20th 2021."
Answered by AI
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