NCT00669565已完成2 期
A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
Peregrine Pharmaceuticals9 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年7月1日最近更新:
适应症
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
- 9
- 主要终点
- The primary objective of this study is to determine the overall response rate (CR+PR)
研究概览
简要总结
This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.
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
- •Living in India for the duration of the study
- •Adult females over age 18 years of age with a life expectancy of at least 3 months
- •Confirmed breast cancer with evidence of locally advanced or metastatic disease
- •Disease that is measurable by radiology imaging
- •Ambulatory and capable of all selfcare but unable to carry out any work activities.
- •Adequate laboratory results (hematologic, renal, hepatic)
- •Negative pregnancy test
排除标准
- •History of or susceptibility to bleeding or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
- •Any history of thromboembolic events (clots within blood vessels)
- •Ongoing treatment with high doses of anticoagulants
- •Use of hormone therapy
- •Advanced peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
- •Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
- •Radiotherapy within 2 weeks entering the study
- •Chemotherapy, immunotherapy or radiotherapy within 4 weeks of starting the study
- •Allergies to Polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
- •Diagnosed and active CNS disease or metastatic lesions
- •Major surgery within 4 weeks of starting the study
- •Pregnant or nursing
- •Uncontrolled disease (e.g., diabetes, hypertension, thyroid disease)
- •History of heart disease
- •History of any condition requiring treatment with anti-inflammatory, anti-platelet drugs or steroids
- •Diagnosed with HIV or hepatitis
结局指标
主要结局
The primary objective of this study is to determine the overall response rate (CR+PR)
时间窗: Until disease progression
次要结局
未报告次要终点
研究者
研究点 (9)
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