NL-OMON52629已完成2 期
Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) - SRA-MMB-4365
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Eligibility Criteria for Subjects Continuing MMB Treatment:
- •1) Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214,
- •GS-US-352-1154, or SRA-MMB-301
- •2) Did not discontinue treatment with MMB for any reason while enrolled in
- •Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
- •3) Negative serum or urine pregnancy test is required for female subjects of
- •childbearing potential as described in Appendix 3
- •4) Male subjects and female subjects of childbearing potential who engage in
- •heterosexual intercourse must agree to use protocol specified method(s) of
- •contraception as described in Appendix 3
- •5) Any Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE]
- •Version 4.03) non-hematologic toxicity in the prior study that the investigator
- •considers related to previous MMB use must have resolved, reverted to Grade 1,
- •or reverted to baseline within the 30 days from the last MMB administration to
- •Day 1 of this study
- •6) Any adverse event (AE) requiring MMB interruption during the prior study
- •must have resolved, reverted to Grade 1, or reverted to baseline within the 30
- •days from last MMB administration to Day 1 of this study
- •7) Ability and agreement to attend protocol-specified visits at the study site
- •8) Able to comprehend and willing to sign the informed consent form
- •Eligibility Criteria for Subjects Enrolling for Survival Follow-Up Only:
- •1) Participating in survival follow-up after discontinuation of treatment in
- •study SRA-MMB-301
排除标准
- •1) Known hypersensitivity to MMB, its metabolites, or formulation excipients
- •2) Incomplete recovery from major surgery prior to Day 1 of this study
- •3) Pregnant or lactating females
- •4) Presence of * Grade 3 (CTCAE Version 4.03) peripheral neuropathy
- •5) Known positive status for human immunodeficiency virus (HIV)
- •6) Known chronic active or acute viral hepatitis A, B, or C infection
研究者
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