A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

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Description

This is a Phase 2 open label study of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in participants with polycythemia vera. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with PV; and inhibition of LSD1 by bomedemstat will induce hematologic response in this population by 36 weeks, improve symptom burden and reduce spleen size in participants with enlarged spleen at baseline.

Targeted Conditions

Study Overview

Start Date
September 7, 2023
Completion Date
April 14, 2025
Enrollment
20
Date Posted
September 28, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
BRCR Global ( Site 0120)
Plantation, Florida 33322, United States

Hematology Oncology of the North Shore ( Site 0104)
Skokie, Illinois 60076-1264, United States

University of Michigan Comprehensive Cancer Center ( Site 0008)
Ann Arbor, Michigan 48109, United States

Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)
Las Vegas, Nevada 89128, United States

Duke University Medical Center ( Site 0016)
Durham, North Carolina 27705, United States

OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)
Portland, Oregon 97239-4503, United States

Huntsman Cancer Hospital at the University of Utah ( Site 0119)
Salt Lake City, Utah 84112, United States

Monash Medical Centre ( Site 0006)
Clayton, Victoria 3168, Australia

Royal Perth Hospital ( Site 0504)
Perth, Western Australia 6000, Australia

Gloucestershire Royal Hospital ( Site 0205)
Gloucester, England GL1 3NN, United Kingdom

United Lincolnshire Hospitals NHS Trust ( Site 0204)
Lincoln, Great Britain LN2 5QY, United Kingdom

Imperial College London ( Site 0025)
London, Great Britain W12 0HS, United Kingdom

Boston Pilgrim Hospital ( Site 0207)
Boston, Lincolnshire PE21 9QS, United Kingdom

Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)
London, London, City Of SE1 9RT, United Kingdom

Royal Gwent Hospital ( Site 0201)
Newport, Wales NP9 2UB, United Kingdom

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
Has a bone marrow fibrosis score of Grade 0 or Grade 1
Has failed at least one standard cytoreductive therapy to lower hematocrit
Has a life expectancy >36 weeks
Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation

Exclusion Criteria:

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1)
Has an uncontrolled active infection
Has a known human immunodeficiency virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection
Has evidence of increased risk of bleeding, including known bleeding disorders
Is pregnant or lactating

Study Contact Info

Study Contact Name
Toll Free Number
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
Detailed Description
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in participants with PV.

Participants will receive 36 weeks of dosing and may qualify for additional treatment thereafter.

Participants will be followed closely throughout the study for both adverse events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines.

To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers.
NCTid (if applicable)
NCT05558696