NCT00669591已完成2 期
A Phase II Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Breast Cancer
Peregrine Pharmaceuticals4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年1月最近更新:
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
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
研究概览
简要总结
The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult females over age 18 with life expectancy of at least 3 months
- •Histologically or cytologically confirmed locally advanced or metastatic breast cancer
- •One and only one prior chemotherapy regimen (no prior docetaxel)
- •Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
- •Adequate hematologic, renal, and hepatic function;
排除标准
- •Known history of bleeding diathesis or coagulopathy
- •Any current evidence of clinically significant bleeding
- •Any history of thromboembolic events
- •Concurrent hormone therapy
- •Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
研究组 & 干预措施
1
Experimental
Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression
干预措施: Bavituximab (Drug)
结局指标
主要结局
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer
时间窗: Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.
次要结局
- Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.(Approximately 1 year)
研究者
研究点 (4)
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