Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 53
- 主要终点
- PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.
详细描述
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Must have evidence of confirmed metastatic prostate cancer
- •Serum testosterone must be less than 50 ng/mL
- •Disease must be progressing despite anti-androgen therapy
- •PSA level must be elevated
- •Additional criteria determined at screening visit
排除标准
- •Any previous cytotoxic chemotherapy for prostate cancer
- •Use of any investigational drug in the last 4 weeks
- •Symptomatic brain tumors requiring radiation to the brain
- •Active infection
- •Additional criteria determined at screening visit
研究组 & 干预措施
Arm 1
干预措施: Sagopilone (ZK 219477) + prednisone (Drug)
结局指标
主要结局
PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles
时间窗: at least 28 days post day 21 of last cycle of treatment
次要结局
- Safety & Tolerability of ZK-Epo plus prednisone(until progression, unknown duration)