A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients with Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study - IMG-7289-CTP-202 Phase 2 Myeloproliferative Neoplasms Study

Imago BioSciences Inc.0 个研究点目标入组 80 人开始时间: 2021年9月21日最近更新: 2024年3月12日

研究概览

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•Patients must meet all of criteria to be eligible for study enrollment:
•1. 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).
•2. In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•Patients will be excluded from the study if they meet any of the following criteria:
•1. Ongoing participation in another investigational study (except observational studies).
•2. A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
•3. Current use of a prohibited medication (e.g., romiplostim).
•4. 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.
•5. Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
•6. Women of childbearing potential (WOCBP) and fertile men (see Section 6.1) unwilling to agree to use an approved method of contraception from time of enrollment until 14 days* after last bomedemstat dose. Methods of contraception include: estrogen and progestogen combined hormonal contraception which inhibits ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); bilateral tubal occlusion; vasectomized partner in a monogamous sexual relationship (vasectomy or tubal ligation at least six months prior to dosing); and, complete sexual abstinence (defined as refraining from heterosexual intercourse). Patients practicing abstinence must agree to use an approved method of contraception if they become sexually active during the study.

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