Myelodysplastic Syndrome Clinical Trial
A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)
This is a Phase 2 open label study of an orally administered LSD1 inhibitor, bomedemstat (IMG-7289), in patients with polycythemia vera.
This study investigates the following:
The safety and tolerability of bomedemstat
The pharmacodynamic effect of bomedemstat
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.
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
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
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