NCT00036036已完成2 期
Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.
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
- •Measurable metastatic or locally advanced disease.
- •Histologically confirmed renal cell cancer.
- •No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
- •Expected remaining life span > or = three months.
- •ECOG performance status 0-
- •> or = 18 years of legal age.
- •Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
- •Negative serum pregnancy test, if fertile female.
- •Willingness and ability to sign an informed consent document.
排除标准
- •Uncontrolled or symptomatic brain metastases.
- •Use of an investigational medication or device within one month of initiating study therapy.
- •Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN.
- •Any condition or any medication which may interfere with the conduct of the study.
- •Current active malignancy other than renal cell cancer.
研究者
研究点 (2)
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