Myeloproliferative Neoplasms Clinical Trial
Extension Study of Bomedemstat (IMG-7289) in Patients With Myeloproliferative Neoplasms
Summary
This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat administered orally once daily in patients with an MPN who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102 and IMG-7289-CTP-201 (referred to hereafter as 'feeder studies').
Eligibility Criteria
Inclusion Criteria:
Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201).
In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
Exclusion Criteria:
Ongoing participation in another investigational study (except observational studies).
A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
Current use of a prohibited medication (e.g., romiplostim).
Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.
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There are 18 Locations for this study
Miami Florida, 33136, United States
Ann Arbor Michigan, 48109, United States
Cleveland Ohio, 44195, United States
Pittsburgh Pennsylvania, 15232, United States
Seattle Washington, 98109, United States
Camperdown New South Wales, 2050, Australia
Saint Leonards New South Wales, 2065, Australia
Southport Queensland, 4215, Australia
Adelaide South Australia, 5000, Australia
Essen , 45147, Germany
Hong Kong , , Hong Kong
Varese VA, 2100, Italy
Alessandria , 15121, Italy
Firenze , 50134, Italy
Pavia , 27100, Italy
Papatoetoe Aukland, 2025, New Zealand
Takapuna Aukland, 0622, New Zealand
London , NW1 1, United Kingdom
London , SE1 9, United Kingdom
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