NCT00517790已完成2 期
An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
AbbVie (prior sponsor, Abbott)28 个研究点 分布在 5 个国家目标入组 140 人开始时间: 2007年8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
- 140
- 试验地点
- 28
- 主要终点
- Progression Free Rate (PFR)
研究概览
简要总结
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.
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
- 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
- •Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC
- •Subjects must have at least one lesion measurable by CT scan as defined by RECIST
- •The measurable lesion may have not received radiation therapy
- •Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
- •Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC
- •Adequate organ function
排除标准
- •Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed.
- •Subject has untreated brain or meningeal metastases.
- •History of greater than 10% weight loss
- •Subject has clinically relevant hemoptysis
- •The subject has proteinuria CTC Grade > 1
- •The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.
- •The subject has a documented left ventricular ejection fraction < 50%
研究组 & 干预措施
ABT-869 0.25 mg/kg
Experimental
Approximately half of the subjects were randomized to receive the high dose
干预措施: ABT-869 .25 mg/kg (Drug)
ABT-869 0.10 mg/kg
Experimental
Approximately half of the subjects were randomized to receive the Low Dose
干预措施: ABT-869 0.10 mg/kg (Drug)
结局指标
主要结局
Progression Free Rate (PFR)
时间窗: Week 16
次要结局
- Objective Response Rate(Week 16)
研究者
研究点 (28)
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