NCT00047216已完成2 期
A Phase II Study of R115777 (Zarnestra) in Superficial Transitional Cell Carcinoma of Bladder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 14
- 主要终点
- 1-year recurrence-free survival
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent bladder cancer.
详细描述
OBJECTIVES:
- Determine the 1-year recurrence-free survival rate of patients with stage 0 or I recurrent transitional cell carcinoma of the bladder treated with tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
1-year recurrence-free survival
次要结局
- Molecular changes in the host tissue
- Progression rate at 3, 6, 9, and 12 months
- Recurrence rate at 3, 6, 9, and 12 months
- Time to treatment failure
- Survival rate
研究者
研究点 (14)
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