A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator
研究概览
简要总结
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 years or older
- •Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination
排除标准
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
研究组 & 干预措施
Ixabepilone
干预措施: Ixabepilone (Drug)
结局指标
主要结局
Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator
时间窗: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
时间窗: 21-day cycles until documented disease progression or unacceptable toxicity
次要结局
- Secondary objectives will be assessed by combining data with the previous Phase II study CA163107(21-day cycles until documented disease progression or unacceptable toxicity)
- To evaluate the antitumor response according to the RECIST criteria(21-day cycles until documented disease progression or unacceptable toxicity)
- To evaluate the duration of achieved responses(21-day cycles until documented disease progression or unacceptable toxicity)
- To evaluate time to progression (TTP)(21-day cycles until documented disease progression or unacceptable toxicity)