NCT00160069已完成2 期
Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 128
- 主要终点
- The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
研究概览
简要总结
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung 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
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small-cell lung cancer
- •Only one previous chemotherapy with a platinum-containing drug
- •Use of highly effective birth control methods in females of child-bearing potential
排除标准
- •No more than 1 previous chemotherapy for advanced disease
- •Previous participation in another trial within the last 4 weeks
- •Breast feeding
- •Active infections
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Arm 2
Experimental
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
Arm 3
Experimental
干预措施: Sagopilone (BAY86-5302, ZK 219477) (Drug)
结局指标
主要结局
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
时间窗: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
次要结局
- Secondary objectives : investigate the safety and tolerability of ZK 219477(Continuously)
研究者
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