NCT00870337已完成2 期
Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer
ARCAGY/ GINECO GROUP1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor 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 everolimus works in treating patients with relapsed or metastatic endometrial cancer.
详细描述
OBJECTIVES:
Primary
- Estimate the rate of non-progression after 3 months of treatment with everolimus in patients with relapsed or metastatic endometrial cancer.
Secondary
- Evaluate the partial and complete response rate after 3 months of treatment with everolimus in these patients.
- Evaluate the duration of response in these patients.
- Evaluate the clinical benefit after 6 months of treatment with everolimus in these patients.
- Evaluate the time to progression in these patients.
- Evaluate the progression-free and overall survival of these patients.
- Evaluate the nature, frequency, and severity of side effects of everolimus in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 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
Single arm
Experimental
干预措施: everolimus (Drug)
结局指标
主要结局
Rate of non-progression after 3 months of treatment with everolimus as assessed by RECIST criteria
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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