A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
研究概览
简要总结
This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must have already received tremelimumab in another protocol
- •Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
- •Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures
排除标准
- 未提供
研究组 & 干预措施
1
Drug: CP-675,206 (Tremelimumab)
干预措施: CP-675,206 (Tremelimumab) (Drug)
结局指标
主要结局
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.
时间窗: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Serious Adverse Events to Tremelimumab.
时间窗: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Survival
时间窗: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.
时间窗: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)
时间窗: Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
次要结局
- Disease Free Survival(Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.)