NCT00054886已完成2 期
Phase II Study Of Single-Agent SU011248 In The Second-Line Treatment Of Patients With Metastatic Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 63
- 试验地点
- 16
- 主要终点
- The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
研究概览
简要总结
The primary goal of the study is to evaluate the effectiveness and safety of SU-011,248 as a treatment for metastatic kidney cancer.
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
- •Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer.
- •The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given.
- •Any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function
排除标准
- •Prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen;
- •Prior surgical resection of or irradiation to the only site of measurable disease;
- •Ongoing severe hematuria;
- •Other active second malignancy;
- •Cardiovascular diseases or conditions within the last 12 months;
- •Known brain metastases;
- •Known HIV-positive or AIDS-related illness;
- •Pregnant or breast-feeding women;
- •Current participation in other clinical trials;
- •Other severe acute or chronic medical conditions.
结局指标
主要结局
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
次要结局
- The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
研究者
研究点 (16)
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