A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective Response (Partial and Complete) Per RECIST
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
详细描述
PRIMARY OBJECTIVES:
I. Assess the efficacy of sunitinib malate, in terms of response rate (complete and partial), in patients with malignant pleural mesothelioma.
II. Assess the toxicity, safety, and tolerability of this drug in these patients.
III. Assess the duration of response or stable disease, stable disease rate, progression-free survival, and median and overall survival rates.
OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (sunitinib malate)
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Objective Response (Partial and Complete) Per RECIST
时间窗: Up to 3 years
Number of patients who had objective responses after radiology review
次要结局
未报告次要终点