NCT00541008已完成2 期
Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 92
- 试验地点
- 44
- 主要终点
- Objective tumor response rate
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
详细描述
OBJECTIVES:
Primary
- To determine the objective tumor response rate in patients with locally advanced or metastatic papillary renal cell carcinoma treated with sunitinib malate.
Secondary
- To evaluate the safety of this drug in these patients.
- To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Objective tumor response rate
次要结局
- Time to disease progression
- Safety
- Duration of response
- Overall survival
- Time to response
研究者
研究点 (44)
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