NCT00519324已完成2 期
A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.
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
- 20 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
RAD001
Experimental
干预措施: Everolimus (Drug)
结局指标
主要结局
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
时间窗: 18 months
次要结局
- To assess progression free survival (PFS) and overall survival (OS)(18 months)
- Objective response rate (ORR) assessed by RECIST criteria(18 months)
- To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0(18 months)
研究者
研究点 (2)
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