Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Number of subjects with permanent discontinuations
研究概览
简要总结
The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available
排除标准
- •Patients alive at study initiation who have not received information notice
- •who have opposed to data collection.
结局指标
主要结局
Number of subjects with permanent discontinuations
时间窗: during the whole study period for a maximum of 28 to 31 months
Average Daily Dose
时间窗: during the whole study period for a maximum of 28 to 31 months
average daily dose received by subject during the treatment exposure
Number of subjects with ≥1 temporary interruptions
时间窗: during the whole study period for a maximum of 28 to 31 months
Number of interruptions per subject
时间窗: during the whole study period for a maximum of 28 to 31 months
Number of subjects with ≥1 dose modification(s)
时间窗: during the whole study period for a maximum of 28 to 31 months
Dose prescribed at initiation
时间窗: during the whole study period for a maximum of 28 to 31 months
Duration of treatment exposure
时间窗: during the whole study period for a maximum of 28 to 31 months
次要结局
- Overall survival of subjects since RCC diagnosis.(during the whole study period for a maximum of 28 to 31 months)
- Overall survival of subjects since metastatic diagnosis(during the whole study period for a maximum of 28 to 31 months)
- Overall survival of subjects since cabozantinib initiation(during the whole study period for a maximum of 28 to 31 months)