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

Last updated: November 22, 2024
Sponsor: Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Overall Status: Active - Not Recruiting

Phase

2

Condition

Leukemia (Pediatric)

Bone Marrow Disorder

Red Blood Cell Disorders

Treatment

Bomedemstat

bomedemstat

Clinical Study ID

NCT05558696
3543-004
MK-3543-004
IMG-7289
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of the orally administered lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat, in participants with polycythemia vera (PV). At Week 36 of dosing, participants will be assessed for eligibility to receive additional treatment through Week 52. Participants deriving clinical benefit and safely tolerating bomedemstat will qualify for continued treatment at the Investigator's discretion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnosticcriteria 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

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 orHepatitis C virus infection

  • Has evidence of increased risk of bleeding, including known bleeding disorders

  • Is pregnant or lactating

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Bomedemstat
Phase: 2
Study Start date:
September 07, 2023
Estimated Completion Date:
March 24, 2025

Study Description

With Amendment 3, after all ongoing participants have reached 52 weeks of treatment, eligible participants may transition to a bomedemstat extension study if available. With Amendment 4, all secondary PK and patient reported outcome measures were designated as exploratory.

Connect with a study center

  • Sunshine Coast Hematology and Oncology Clinic (Site 0506)

    Sunshine Coast, Queensland 4556
    Australia

    Site Not Available

  • Monash Medical Centre ( Site 0006)

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Royal Perth Hospital ( Site 0504)

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Gloucestershire Royal Hospital ( Site 0205)

    Gloucester, England GL1 3NN
    United Kingdom

    Site Not Available

  • United Lincolnshire Hospitals NHS Trust ( Site 0204)

    Lincoln, Great Britain LN2 5QY
    United Kingdom

    Site Not Available

  • Imperial College London ( Site 0025)

    London, Great Britain W12 0HS
    United Kingdom

    Site Not Available

  • Boston Pilgrim Hospital ( Site 0207)

    Boston, Lincolnshire PE21 9QS
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust - Guys Hospital ( Site 0020)

    London, London, City Of SE1 9RT
    United Kingdom

    Site Not Available

  • Royal Gwent Hospital ( Site 0201)

    Newport, Wales NP9 2UB
    United Kingdom

    Site Not Available

  • BRCR Global ( Site 0120)

    Plantation, Florida 33322
    United States

    Site Not Available

  • Edward H. Kaplan MD & Associates

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Hematology Oncology of the North Shore ( Site 0104)

    Skokie, Illinois 60076-1264
    United States

    Site Not Available

  • University of Michigan Comprehensive Cancer Center ( Site 0008)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada - Peak ( Site 0118)

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Duke University Medical Center ( Site 0016)

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center ( Site 0103)

    Columbus, Ohio 43203
    United States

    Site Not Available

  • OHSU Knight Cardiovascular Institute Cardiology Clinic - South Waterfront ( Site 0102)

    Portland, Oregon 97239-4503
    United States

    Site Not Available

  • Huntsman Cancer Hospital at the University of Utah ( Site 0119)

    Salt Lake City, Utah 84112
    United States

    Site Not Available

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