NCT00456716已完成2 期
A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
Open label study of sorafenib
详细描述
Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than < 100 cigarettes lifetime).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Life expectancy > 12 weeks
- •Biopsy-proven BAC or adenocarcinoma
- •Willing to provide smoking status
- •Selected IIIB or stage IV cancer that is incompletely resected or unresectable
排除标准
- •O2 saturation < 88% on room air
- •Pregnant or nursing women
- •Surgery or radiation therapy within 4 weeks of starting study
- •Major heart condition within 6 months of starting therapy
- •Certain concomitant medications prohibited
结局指标
主要结局
Response rate
时间窗: January 2009
One-year survival
时间窗: January 2009
Median survival
时间窗: January 2009
次要结局
- Median progression-free survival(January 2009)
- Toxicities(January 2009)
研究者
研究点 (2)
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