NCT00688753已完成2 期
A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer
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
- 92
- 试验地点
- 1
- 主要终点
- To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
研究概览
简要总结
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.
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
RAD001
Experimental
two 5 mg tablets of everolimus orally, once daily
干预措施: RAD001 (Drug)
结局指标
主要结局
To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
时间窗: 6 mos
PFSR at 6 months based on central review
次要结局
- Disease Control Rate (SD + PR + CR)(6 mos)
- Objective Response Rate(End of trial)
- Duration of Response(End of trial)
- Median Progression Free Survival(End of trial)
- Incidence of Adverse Events, Serious Adverse Events, and Death.(End of trial)
研究者
研究点 (1)
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A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer - RAPTORPatients who have metastatic papillary cancer of the kidney and have not received prior systemic treatment for their metastatic RCC. This multicenter international trial will enroll a maximum of 60 patients over a period of approximately 12 months.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2008-006181-28-FRovartis Pharma Services AG60
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A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancerPatients who have metastatic papillary cancer of the kidney and have not received prior systemic treatment for their metastatic RCC. This multicenter international trial will enroll a maximum of 60 patients over a period of approximately 12 months.MedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2008-006181-28-BEovartis Pharma Services AG55
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A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancerEUCTR2008-006181-28-GBovartis Pharma Services AG92