Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Efficacy related variables are patient's performance status.
研究概览
简要总结
The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.
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 with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib
排除标准
- •Exclusion criteria must be read in conjunction with the local product information.
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
Efficacy related variables are patient's performance status.
时间窗: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variable - Quality of Life (QOL) assessment by the patient
时间窗: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are status of tumor / metastases.
时间窗: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Efficacy related variables are efficacy assessment by the physician.
时间窗: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
次要结局
- General tolerability assessment by physician and reports of adverse events.(After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier))