NCT00687817已完成2 期
A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Peregrine Pharmaceuticals17 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2008年6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
- 49
- 试验地点
- 17
- 主要终点
- Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer
研究概览
简要总结
The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung 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
- 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 non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
- •Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
- •Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
- •D-dimer ≤ 2 x ULN
排除标准
- •Small cell or mixed histology
- •Known history of bleeding diathesis or coagulopathy
- •Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
- •Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
- •Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
- •Radiotherapy within 2 weeks preceding Study Day 1
- •Symptomatic or clinically active CNS disease or metastatic lesions
- •Major surgery within 4 weeks of Study Day 1
- •Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
- •Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
- •A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study.
- •Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids
结局指标
主要结局
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer
时间窗: one year
次要结局
- Time to tumor progression, duration of response, overall survival and safety(Approximately 1 year)
研究者
研究点 (17)
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