跳至主要内容
临床试验/NCT00771147
NCT00771147已完成不适用

Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions

Bayer0 个研究点目标入组 71 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
71
主要终点
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated

研究概览

简要总结

Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study

排除标准

  • Exclusion criteria must be read in conjunction with the Belgian 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

Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated

时间窗: At 1, 3, 6 and 9 months and after one year

次要结局

未报告次要终点

研究者

发起方
Bayer
申办方类型
Industry

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