Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 72
- 主要终点
- Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
研究概览
简要总结
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
详细描述
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for gastrointestinal stromal tumors progressed after cancer chemotherapy.
A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are treated with Regorafenib/ STIVARGA and meet the product label.
排除标准
- •Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label.
研究组 & 干预措施
Group 1
Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
时间窗: Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
时间窗: Up to 6 months
Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
时间窗: up to 6 months
次要结局
- tumour response(Up to 3 years)
- overall survival (OS)(Up to 3 years)
- time to treatment failure (TTF)(Up to 3 years)
- Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.(Up to 3 years)