NCT00297089已完成1 期
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT 751 in Combination With Pemetrexed Versus Pemetrexed Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
AbbVie (prior sponsor, Abbott)48 个研究点 分布在 6 个国家目标入组 165 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 48
- 主要终点
- Progression-free Survival
研究概览
简要总结
To determine the efficacy of ABT-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic NSCLC. The Phase 1 portion of the study is complete and the study is currently enrolling subjects in Phase 2.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically documented NSCLC
- •Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
- •Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
- •Only one prior anti-tumor treatment regimen in the curative setting
- •Progressive disease following the previous anti-tumor treatment regimen
- •Measurable disease by RECIST criteria
- •Brain metastasis must be stable and well-controlled
- •ECOG performance score 0-2
- •All anti-tumor therapy discontinued at least 3 weeks prior to study entry
- •All adverse events from prior treatment are resolved or stable
- •Adequate hematologic, renal, and hepatic function
- •Females must not be pregnant
- •Willing to take adequate measures to prevent pregnancy
- •Life expectancy of at least 3 months
- •Able to complete the Quality of Life questionnaire
- •Voluntarily signed informed consent
排除标准
- •Greater than Grade 1 neurological findings
- •Allergy to sulfa medications
- •Previous treatment with ABT-751 or pemetrexed
- •Receipt of more than one investigational agent for NSCLC
- •Significant weight loss (>10%) within 6 weeks of study entry
- •Glucose-6-phosphate dehydrogenase deficiency or porphyria
- •Significant systemic disease that would adversely affect participation
- •Class 3-4 New York Heart Association classification status
- •Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
研究组 & 干预措施
A
Active Comparator
Pemetrexed + ABT-751
干预措施: ABT-751 (Drug)
A
Active Comparator
Pemetrexed + ABT-751
干预措施: pemetrexed (Drug)
B
Placebo Comparator
Pemetrexed + placebo
干预措施: pemetrexed (Drug)
B
Placebo Comparator
Pemetrexed + placebo
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Subjects may remain on study until disease progression.
次要结局
- Overall Survival(Subjects may remain on study until disease progression.)
- Response Rate(Subjects may remain on study until disease progression.)
- Time-to-Progression (TTP)(Subjects may remain on study until disease progression.)
研究者
研究点 (48)
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