A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06351631
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myelofibrosis
  • Polycythemia Vera
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis
  • Thrombocythemia, Essential

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bomedemstat — DRUG
    10, 15, 20, and 50 mg oral capsules

Study Details

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Key Dates

Start date
May 23, 2024
Status verified
Apr 2026
Primary completion
Dec 4, 2034
Completion
Dec 4, 2034

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bomedemstat
    Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.

Primary Outcome Measure

Percentage of participants with one or more adverse events (AEs) [ Time Frame: Up to ~10 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Michigan ( Site 6000)Ann ArborMichigan48109
Study Coordinator
734-763-4695
DUHS Duke Blood Cancer Center ( Site 6005)DurhamNorth Carolina27705
Study Coordinator
919-668-1608
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)ColumbusOhio43210
Study Coordinator
888-577-8839
UPMC Hillman Cancer Center ( Site 6004)PittsburghPennsylvania15232
Study Coordinator
412-864-6627

Find similar trials in Ann Arbor, MI

By research site
University of Michigan· Ann Arbor, MIDUHS Duke Blood Cancer Center· Durham, NCThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C· Columbus, OHUPMC Hillman Cancer Center· Pittsburgh, PA

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