Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The antitumor activity in terms of progression free survival
研究概览
简要总结
Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.
详细描述
This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).
Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.
Treatment with the study drug will continue until tumor progression or unacceptable toxicity.
The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of metastatic renal cancer with non-clear cell
- •No previous treatment
排除标准
- •Prior treatment with an antiangiogenetic compound
- •Symptomatic and/or unstable pre-existing brain metastases
- •Severe or uncontrolled cardiovascular diseases
研究组 & 干预措施
Sunitinib
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
干预措施: Sunitinib (Drug)
结局指标
主要结局
The antitumor activity in terms of progression free survival
时间窗: two years
次要结局
- To evaluate the toxicity and the safety profile(two years)
- To evaluate the objective response rate(two years)
- To evaluate the overall survival(two years)