NCT00846976已完成3 期
A Treatment Protocol to Monitor the Safety of a 200 mg Daily Dose of Bicalutamide (Casodex) in Patients With Advanced Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Safety profile of patients treated with a 200 mg daily dose of CASODEX
研究概览
简要总结
This is an open label, single-centered treatment protocol designed to monitor the safety of patients treated with a 200 mg daily dose of CASODEX. Patient will receive CASODEX as long as physician feels that he is benefiting from this form of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate gland
- •Patients with advanced prostate cancer
- •Adult male over the age of 18 years old
- •Normal liver function (AST < 2 x Upper Limit Normal)
排除标准
- •ECOG performance status of
- •Previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years.
研究组 & 干预措施
200 mg Casodex
Experimental
干预措施: Bicalutamide (Drug)
结局指标
主要结局
Safety profile of patients treated with a 200 mg daily dose of CASODEX
时间窗: every three months
次要结局
未报告次要终点
研究者
研究点 (1)
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