NCT01508364已完成不适用
NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma
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
- 20
- 主要终点
- Duration of Nexavar treatment
研究概览
简要总结
This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.
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 a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar.
- •Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.
排除标准
- •Prior targeted therapy for RCC
- •Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY 43-9006) (Drug)
结局指标
主要结局
Duration of Nexavar treatment
时间窗: up to 3 years
次要结局
- Overall Survival (OS)(1 - 1.5 years after LPLV)
- Health related quality of life (HRQoL)(up to 3 years)
- Tumor status, of patients will be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression".(up to 3 years)
- Incidence of Treatment-emergent Adverse Events (TEAE)(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
研究者
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