EUCTR2017-004350-42-DE进行中（未招募）1 期
Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essentialThrombocythemia Myelofibrosis (Post-PV/ET MF)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 SRAMMB-301
- •3) Any Grade 3 or 4 (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 last MMB administration to Day 1 of this study
- •4) Any 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
- •For subjects enrolling for survival follow-up only:
- •Participating in survival follow-up after discontinuation of treatment in study SRA-MMB-301
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1) Known hypersensitivity to MMB, its metabolites, or formulation excipient
- •2) Incomplete recovery from major surgery prior to Day 1 of this study
- •3) Presence of = Grade 3 (CTCAE Version 4.03) peripheral neuropathy
研究者
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