NCT01138163已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Peregrine Pharmaceuticals53 个研究点 分布在 5 个国家目标入组 121 人开始时间: 2010年6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
- 121
- 试验地点
- 53
- 主要终点
- Objective Response Rate
研究概览
简要总结
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over age 18 years of age with a life expectancy of at least 3 months.
- •Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
- •Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤
- •Adequate hematologic, renal, and hepatic function.
- •PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
- •New York Heart Association classification I or II
排除标准
- •Squamous, small cell, or mixed histology.
- •Known history of bleeding diathesis or coagulopathy.
- •Cavitary tumors or tumors invading or abutting large blood vessels.
- •Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
- •Venous thromboembolic events within 6 months of screening.
- •Ongoing therapy with oral or parenteral anticoagulants.
- •Concurrent estrogens, anti-estrogens or progesterone compounds.
- •Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day
- •Symptomatic or clinically active brain metastases.
- •Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
- •Grade 2 or higher peripheral neuropathy
研究组 & 干预措施
Docetaxel plus bavituximab 1 mg/kg
Experimental
干预措施: Docetaxel plus bavituximab or placebo (Drug)
Docetaxel plus bavituximab 3 mg/kg
Experimental
干预措施: Docetaxel plus bavituximab or placebo (Drug)
Docetaxel plus placebo
Placebo Comparator
干预措施: Docetaxel plus bavituximab or placebo (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Until disease progression
次要结局
未报告次要终点
研究者
研究点 (53)
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