NCT00716534已完成2 期
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
AbbVie (prior sponsor, Abbott)37 个研究点 分布在 6 个国家目标入组 145 人开始时间: 2008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
- 145
- 试验地点
- 37
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
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
- Double (Participant, Investigator)
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 at least 18 years of age.
- •Subject must have cytologically or histologically confirmed non-squamous NSCLC
- •Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
- •Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
- •Subject has an ECOG Performance Score of 0-
- •Willing to take adequate measures to prevent pregnancy.
排除标准
- •The subject has NSCLC with a predominant squamous cell histology
- •Subject has hypersensitivity to paclitaxel.
- •Subject has received any anti-cancer therapy for treatment of NSCLC.
- •Subject has received radiation therapy within 21 days of Study Day
- •Subject has had major surgery within 21 days.
- •Subject has untreated brain or meningeal metastases.
- •Subject is receiving therapeutic anticoagulation therapy.
- •Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
- •Subject has proteinuria CTC Grade > 1 at baseline.
- •Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
- •The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
- •The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day
- •The subject has a documented left ventricular (LV) ejection fraction < 50%.
- •The subject has known autoimmune disease with renal involvement (i.e., lupus).
- •The subject is receiving combination anti-retroviral therapy for HIV.
- •The subject has clinically significant uncontrolled condition(s).
- •The subject has a history of another active cancer within the past 5 years.
- •The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
- •The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
- •The subject is pregnant or breast feeding.
研究组 & 干预措施
A
Experimental
12.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: ABT-869 (Drug)
A
Experimental
12.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
A
Experimental
12.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
B
Experimental
7.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: ABT-869 (Drug)
B
Experimental
7.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
B
Experimental
7.5 mg ABT-869 + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
C
Placebo Comparator
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
干预措施: Placebo for ABT-869 (Drug)
C
Placebo Comparator
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
干预措施: Carboplatin (Drug)
C
Placebo Comparator
Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Disease Progression
次要结局
- Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response(Disease Progression)
- Survival Rate(12 Months)
研究者
研究点 (37)
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