NCT00635856已完成2 期
Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 100
- 主要终点
- Serum Prostate Specific Antigen
研究概览
简要总结
A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Prostate cancer diagnosis
- •no evidence of metastasis
- •Age 18 or older
排除标准
- •Prior chemotherapy for recurrent prostate cancer
- •Radiotherapy completed within 28 days of starting the study
- •Incomplete healing from prior cancer or other major surgery
结局指标
主要结局
Serum Prostate Specific Antigen
时间窗: Monthly
次要结局
- Duration of PSA decline(Monthly)
- Safety variables(Monthly)
- Time to Progression(Every 3 months)
研究者
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