NCT00063102已完成2 期
A Phase II Study of ABT-751 in Patients With Breast Cancer Refractory to Taxane Regimens
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Objective Response Rate in subjects with Breast cancer
研究概览
简要总结
The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.
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
- •Stage IIIB or IV breast cancer.
- •Recurrent tumor after or while on taxane therapy (taxol or taxotere).
- •Able to tolerate normal activities of daily living.
- •Adequate bone marrow, kidney and liver function.
排除标准
- •Pregnant or breast feeding.
- •No anti-tumor therapy (including hormonal therapy or Herceptin) within 4 weeks of the start of ABT-751 administration.
结局指标
主要结局
Objective Response Rate in subjects with Breast cancer
时间窗: 1 year
次要结局
- Time to Tumor Progression (TTP)(1 year)
- Survival(2 years)
- Toxicities associated with treatment administration(1 year)
研究者
研究点 (13)
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