A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Measure number of severe side effects seen during first cycle of therapy
研究概览
简要总结
This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
详细描述
Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.
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
- •Greater than or equal to 18
- •Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
- •Evaluable disease by clinical or radiographic parameters
- •No history or concomitant malignancy
- •Adequate organ and marrow function
- •Female subjects with negative urine or serum pregnancy
- •ECOG must be 0 or 1
排除标准
- •Squamous cell, small cell, or mixed histology
- •Known history of bleeding diathesis or coagulopathy
- •Cavitary tumors or tumors invading or abutting large blood vessels
- •Any history of thromboembolic events
- •Ongoing therapy with oral or parenteral anticoagulants
- •Major surgery within 4 weeks of Day 1 of treatment
- •Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)
- •any history of significant vascular disease
- •Congestive heart failure
- •History of any condition requiring anti-platelet therapy
- •Serious non healing wound
- •Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
- •Unable or unwilling to discontinue use of prohibited medications
- •D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart
研究组 & 干预措施
Single-arm trial
Single-arm trial
干预措施: Bavituximab (Drug)
结局指标
主要结局
Measure number of severe side effects seen during first cycle of therapy
时间窗: Three weeks
To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed
次要结局
- Progression free survival(At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death)