NCT00226980已完成2 期
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
研究概览
简要总结
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and sign an IRB approved Informed consent
- •Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
- •Male or female 18 years or older
- •Willing to use contraception
- •Pathologic diagnosis of renal cell carcinoma
- •Bi-dimensionally measurable disease
- •Evidence of disease progression prior to start of treatment
- •Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
- •Adequate hematologic data: ANC.1.5; platelets>100x10^9
- •Adequate renal function: Creatinine clearance .50cc
- •Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN
- •ECOG performance status 0-1
排除标准
- •Known brain metastases.
- •Peripheral neuropathy.
- •Pregnant and/ or lactating female.
- •Unable to take a baby aspirin.
结局指标
主要结局
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
次要结局
- Safety of the combination
研究者
研究点 (2)
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