Spots Global Cancer Trial Database for A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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Trial Identification
Brief Title: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Official 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
Study ID: NCT06351631
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000), Adelaide, South Australia, Australia
North Shore Hospital-Department of Haematology ( Site 1401), Auckland, , New Zealand
Aotearoa Clinical Trials ( Site 1400), Auckland, , New Zealand
Contact Details
Name: Medical Director
Affiliation: Merck Sharp and Dohme LLC
Role: STUDY_DIRECTOR
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