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Brief Title: A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)
Official Title: A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
Study ID: NCT05558696
Brief Summary: 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. With Amendment 3, after all ongoing patients have reached 52 weeks of treatment, eligible patients may transition to a bomedemstat extension study if available.
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
BRCR Global ( Site 0120), Plantation, Florida, United States
Hematology Oncology of the North Shore ( Site 0104), Skokie, Illinois, United States
University of Michigan Comprehensive Cancer Center ( Site 0008), Ann Arbor, Michigan, United States
Comprehensive Cancer Centers of Nevada - Peak ( Site 0118), Las Vegas, Nevada, United States
Duke University Medical Center ( Site 0016), Durham, North Carolina, United States
Ohio State University Comprehensive Cancer Center ( Site 0103), Columbus, Ohio, United States
OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102), Portland, Oregon, United States
Huntsman Cancer Hospital at the University of Utah ( Site 0119), Salt Lake City, Utah, United States
Monash Medical Centre ( Site 0006), Clayton, Victoria, Australia
Royal Perth Hospital ( Site 0504), Perth, Western Australia, Australia
Gloucestershire Royal Hospital ( Site 0205), Gloucester, England, United Kingdom
United Lincolnshire Hospitals NHS Trust ( Site 0204), Lincoln, Great Britain, United Kingdom
Imperial College London ( Site 0025), London, Great Britain, United Kingdom
Boston Pilgrim Hospital ( Site 0207), Boston, Lincolnshire, United Kingdom
Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020), London, London, City Of, United Kingdom
Royal Gwent Hospital ( Site 0201), Newport, Wales, United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR