Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 82
- 主要终点
- Tumor response rate (complete or partial response according to RECIST)
研究概览
简要总结
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastatic breast cancer
- •No previous treatment with taxanes, and vinca alkaloids
- •Use of highly effective birth control methods in females of child-bearing potential
排除标准
- •More than 2 previous chemotherapies
- •Previous participation in another trial within the last 4 weeks
- •Breast feeding
- •Active infections
研究组 & 干预措施
Arm 2
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Arm 3
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Arm 4
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Arm 1
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
结局指标
主要结局
Tumor response rate (complete or partial response according to RECIST)
时间窗: Every 6 weeks
The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).
次要结局
- Duration of complete or partial tumor response(Every 6 weeks)
- Time to tumor progression(Every 6 weeks)