NCT00372788已完成2 期
A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen
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
- AstraZeneca
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Assess tumor growth
研究概览
简要总结
The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.
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
- •Diagnosed with non-small cell lung cancer
- •Previously received one or two chemotherapeutic treatments
排除标准
- •Previous therapy with MEK inhibitor or pemetrexed
- •Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases
研究组 & 干预措施
1
Active Comparator
Pemetrexed
干预措施: Pemetrexed (Drug)
2
Experimental
AZD6244
干预措施: AZD6244 (Drug)
结局指标
主要结局
Assess tumor growth
时间窗: assessed every 12 weeks
次要结局
- Assess safety and tolerability of AZD6244(assessed at each visit)
研究者
研究点 (1)
Loading locations...
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