A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Safety (Number of patients with adverse events and/or dose-limiting toxicities)
研究概览
简要总结
The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.
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
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
干预措施: Linifanib (Drug)
Arm A
干预措施: Carboplatin (Drug)
Arm A
干预措施: Paclitaxel (Drug)
Arm B
干预措施: Linifanib (Drug)
Arm B
干预措施: Carboplatin (Drug)
Arm B
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Safety (Number of patients with adverse events and/or dose-limiting toxicities)
时间窗: At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
次要结局
- Preliminary tumor response(Week 54)