An Open-Label, Multicenter, Rollover Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 18
- 主要终点
- Frequency and types of adverse events and serious adverse events
研究概览
简要总结
The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated.
This study will also provide another mechanism for reporting adverse events related to study drug safety.
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 and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
- •Currently tolerating treatment in the parent protocol.
- •Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator.
- •Have at least stable disease, as determined by the investigator.
- •Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
排除标准
- •Has been permanently discontinued from study treatment in the parent study for any reason.
- •Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
研究组 & 干预措施
Ruxolitinib
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
干预措施: Ruxolitinib (Drug)
Ruxolitinib plus background cancer therapy
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
干预措施: Regorafenib (Drug)
Background cancer therapy alone
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
干预措施: Capecitabine (Drug)
Ruxolitinib plus background cancer therapy
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
干预措施: Capecitabine (Drug)
Ruxolitinib plus background cancer therapy
Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.
干预措施: Ruxolitinib (Drug)
Background cancer therapy alone
Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.
干预措施: Regorafenib (Drug)
结局指标
主要结局
Frequency and types of adverse events and serious adverse events
时间窗: Maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months.
Subjects will be treated until disease progression or discontinuation criteria are met.
次要结局
未报告次要终点