NCT00830895已完成2 期
A Phase II Study to Evaluate the Efficacy of RAD001 in Metastatic Non-clear Cell Renal Cell Carcinoma
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
- 49
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To assess the efficacy and safety of RAD001 (everolimus) in non-clear cell renal cell carcinoma
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
- •Histologically or cytologically confirmed non-clear cell renal cell carcinoma (papillary, chromophobe, collecting duct, oncocytic subtype, sarcomatoid mainly)
- •Subjects with metastatic legion
- •Subjects aged 18 years or older
- •Subjects whose ECOG performance status is 0 or 1
- •Subjects who have laboratory value below; Hematology
- •Neutrophil >= 1.5 x 109/L
- •Platelet >= 75 x 109/L
- •Hemoglobin >= 9 g/dL Liver function tests
- •Total bilirubin ≤ 1.5 xULN
- •AST, ALT ≤ 2.5 xULN
- •Alkaline phosphatase ≤ 2.5 xULN Renal function tests
- •Creatinine clearance >= 30 mL/min
- •Subjects who understand and provide a written informed consent
排除标准
- •Subjects who have been administered an mTOR inhibitor
- •Pregnant or nursing women, and women of childbearing potential must use appropriate contraception for the study period and the result of their pregnancy test performed within 14 days before enrollment must be negative
- •Subjects who participated in a clinical study using the study medication within 30 days before randomization
- •Subjects with clinically uncontrolled central nervous system (CNS) metastasis
- •Subjects with life expectancy of less than 3 months
- •Subjects with interstitial pulmonary disease
- •Subjects whose QTc interval is prolonged (QTc > 450 msec for male or > 470 msec for female)
- •Other serious diseases or medical conditions Heart disease unstable despite treatment History of myocardial infarction within six months before the study History of serious neurological or psychological disorder including dementia or seizure Active peptic ulcer which cannot be controlled by a drug
研究组 & 干预措施
RAD001
Experimental
RAD001 10mg/day
干预措施: RAD001 (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 months, 4 months, 6 months
It is the time from treatment initiation until disease progression.
次要结局
- Response rate(2 months, 4 months, 6 months)
- Metabolic response rate by FDG-PET(2 months, 4 months, 6 months)
- Safety(monthly)
- Disease-control rate(2 months, 4 months, 6 months)
- Overall survival(2 months, 4 months, 6 months)
研究者
Se-Hoon Lee
Associate Professor
Seoul National University Hospital
研究点 (1)
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