NCT00080262已完成2 期
Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine
R-Pharm1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2004年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Response rate as determined by the IRRC
研究概览
简要总结
The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant
- •No more than 3 prior chemotherapy regimens in the metastatic setting
- •Must have at least one target lesion that is radiographically measurable
- •Good performance status
- •No history of or current brain or leptomeningeal disease
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Response rate as determined by the IRRC
次要结局
- Time to progression, duration of response, overall survival
研究者
研究点 (1)
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