Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 主要终点
- Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities
研究概览
简要总结
This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
- •Able to comprehend and willing to sign informed consent form
排除标准
- •Known hypersensitivity to momelotinib, its metabolites, or formulation excipients
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1
Participants previously enrolled in Study CCL09191E will receive momelotinib for approximately 4 years.
干预措施: Momelotinib (Drug)
Cohort 2
Participants previously enrolled in Study YM387-II-02 will receive momelotinib for approximately 4 years.
干预措施: Momelotinib (Drug)
Cohort 3
Participants previously enrolled in Study GS-US-354-0101 will receive momelotinib for up to 4 years.
Cohort 3 was closed and all enrolled participants were discontinued from this study because parent Study GS-US-354-0101 was terminated.
干预措施: Momelotinib (Drug)
Cohort 4
Participants previously enrolled in Study GS-US-352-1672 will receive momelotinib for approximately 4 years.
干预措施: Momelotinib (Drug)
结局指标
主要结局
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities
时间窗: From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.
Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study.
次要结局
- Duration of Splenic Response(From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Splenic Response Rate(From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Transfusion Independence Response Rate(From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Duration of Transfusion Independence Response(From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Anemia Response Rate(From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Duration of Anemia Response(From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.)
- Rate of RBC Transfusion(From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.)
- Overall Survival(From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib.)
- Progression-Free Survival(From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.)
- Leukemia-Free Survival(From baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.)