Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a Phase 2b open label study of an orally administered LSD1 inhibitor, Bomedemstat
(MK-3543, formerly called IMG-7289), in patients with essential thrombocythemia.
This study investigates the following:
- The safety and tolerability of Bomedemstat
- The pharmacodynamic effect of Bomedemstat
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
Enrollment Eligibility
Inclusion Criteria:
- Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic
criteria for myeloproliferative neoplasms.
- Requires treatment in order to lower platelet count based on patient age over 60 or
history of thrombosis.
- Have failed at least one standard therapy
- Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to
study drug initiation.
Exclusion Criteria:
- Has undergone major surgery ≤4 weeks prior to starting study drug or has not recovered
from side effects of such surgery.
- Unresolved treatment related toxicities from prior therapies (unless resolved to ≤
Grade 1).
- Uncontrolled active infection.
- Current use of prohibited medications
- Known HIV infection or active Hepatitis B or Hepatitis C virus infection
- Other hematologic/biochemistry requirements, as per protocol
- Use of investigational agent within last 14 days
- Pregnant or lactating females