Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Number of Participants Who Received Dasatinib Treatment
研究概览
简要总结
The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participated in and completed a previous dasatinib protocol (including but not limited to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving benefit from dasatinib as defined by the previous protocol
- •Receiving dasatinib at the time of signature of informed consent
- •Males and Females, ages 18 and older
排除标准
- •All patients previously discontinued from a dasatinib study for any reason
- •Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- •History of allergy to dasatinib
研究组 & 干预措施
Dasatinib
This is a continuation roll-over study for patients receiving benefit from prior dasatinib protocols. All subjects will receive dasatinib as per previous protocol
干预措施: Dasatinib (Drug)
结局指标
主要结局
Number of Participants Who Received Dasatinib Treatment
时间窗: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Number of participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
Duration of Treatment
时间窗: From first dose on this study (CA180-597) to last dose on this study (up to approximately 76 months)
Duration of treatment for participants who received dasatinib treatment for prostate cancer and chronic phase chronic myeloid leukemia who had also participated on prior protocols CA180-227, CA180-363 and CA180-056 investigating dasatinib. Dasatinib tablet administered once a day by mouth.
次要结局
- Number of Participants With Adverse Events(From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months))
- Number of Participants With Serious Adverse Events(From first dose on this study (CA180-597) to 30 days after last dose of study therapy (up to approximately 77 months))