Phase 3 Study to Evaluate Safety and Efficacy of MK-3543
Research type
Research Study
Full title
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
IRAS ID
1009097
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
Research summary
Myeloproliferative Neoplasms (MPNs) are a family of related neoplastic disorders of bone marrow. The MPNs are clonal disorders arising frequently from somatic mutations in a multipotent hematopoietic stem resulting in abnormalities in red cell, granulocyte, and platelet production often in association with marrow fibrosis and extramedullary haematopoiesis (formation of blood cellular components outside of the bone marrow) and, in some cases, evolution to acute myeloid leukaemia.
Bomedemstat is an orally active LSD1 inhibitor, the use of which results in platelet, red cell, and granulocyte production reduction, but is fully reversible when the drug has cleared.
This is an extension study to continue to assess the safety, tolerability, and efficacy of bomedemstat in participants who received bomedemstat in a prior feeder study. Approximately 400 or more participants will be enrolled into this extension trial.
Bomedemstat is a capsule that will be administrated orally once daily. Treatment will begin on day 1 following the screening visit and consist of resuming daily bomedemstat treatment at the same dose determined as safe and efficacious at the end of the participant’s feeder trial with safety and haematologic assessments every 4 weeks (at a minimum). Participants may remain on trial until one or more discontinuation criteria are met.
Participants who are not deriving clinical benefit and show evidence of progression or relapse will discontinue bomedemstat, immediately undergo an End of Trial visit, and have the Safety Follow-up Visit scheduled 30 days after the last dose of trial treatment.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0020
Date of REC Opinion
28 Mar 2024
REC opinion
Further Information Favourable Opinion