A Phase II Study of Ridaforolimus in Patients With Metastatic And/Or Locally Advanced Recurrent Endometrial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 11
- 主要终点
- Objective response measured by RECIST criteria
研究概览
简要总结
RATIONALE: Ridaforolimus 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 the side effects of ridaforolimus and to see how well it works in treating patients with recurrent metastatic and/or locally advanced endometrial cancer.
详细描述
OBJECTIVES:
- To assess the efficacy, in terms of objective response rate, of ridaforolimus, in patients with recurrent metastatic and/or locally advanced endometrial cancer.
- To assess the adverse events, time to progression, and response duration of this drug in these patients.
- To correlate objective tumor response with PTEN expression and other potential markers in primary tumor tissue from these patients.
OUTLINE: This is a multicenter study.
Patients receive oral ridaforolimus once daily on days 1-5 for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples (paraffin block or unstained slides) are analyzed for PTEN gene expression and other mTOR pathway elements to explore possible markers of response or non-progression by immunohistochemistry.
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
- 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
Ridaforolimus
oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
干预措施: ridaforolimus (Drug)
Ridaforolimus
oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
干预措施: gene expression analysis (Genetic)
Ridaforolimus
oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
干预措施: immunohistochemistry staining method (Other)
Ridaforolimus
oral ridaforolimus 40 mg days 1-5 each week (once daily for 5 consecutive days every week; cycle arbitrarily defined as a 4 week period)
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response measured by RECIST criteria
时间窗: every 8 weeks
After every second cycle
Adverse events
时间窗: 4 years
Adverse events will be monitored and assessed from the time of the first dose with overall results being assessed at final analysis.
Time to progression
时间窗: 4 years
Correlation between objective tumor response with PTEN expression and other potential markers
时间窗: 4 years
will be assessed overall at the time of completion of therapy and final analysis.
次要结局
- Response duration(4 years)