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临床试验/NCT00895674
NCT00895674已完成不适用

Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Bayer0 个研究点目标入组 2,840 人开始时间: 2006年7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
2,840
主要终点
Tumor status

研究概览

简要总结

Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

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 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: Nexavar (Sorafenib, BAY43-9006) (Drug)

结局指标

主要结局

Tumor status

时间窗: After about 3, 6, 9 and 12 months

次要结局

  • Treatment duration(At end of study after about 12 months)
  • Safety of sorafenib treatment(At every documented visit for about 12 months)
  • Progression-free survival(Calculation at end of study after about 12 months)
  • Status of Metastases(After about 3, 6, 9 and 12 months)
  • Performance status (ECOG)(After about 3, 6, 9 and 12 months)

研究者

发起方
Bayer
申办方类型
Industry

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