Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 117
- 主要终点
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
研究概览
简要总结
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 received Nexavar for unresectable or advanced renal cell carcinoma
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
时间窗: After Nexavar administration, up to 1 year
次要结局
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, clinical staging of RCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)](After Nexavar administration, up to 1 year)
- Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC](After Nexavar administration, up to 1 year)
- The status of therapy with Nexavar [duration of treatment, daily dose](After Nexavar administration, up to 1 year)