Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.
详细描述
To participate in this study, patients must have disease that can be measured on a CT scan. Brain metastases are OK if stable. Pregnant and/or nursing women may not participate. This drug has been approved by the FDA for the treatment of advanced renal cell cancer and a certain type of stomach/intestinal cancer. Its efficacy in lung cancer in currently unknown. Common side effects include fatigue, nausea, diarrhea, skin reaction, and decreased blood counts.
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
- •Bronchoalveolar carcinoma with disease measurable on CAT scan
- •Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
- •Stage IIIB or IV
排除标准
- •Uncontrolled hypertension
- •Unstable brain metastases
- •Pregnant/nursing women
- •Uncontrolled thyroid disease
结局指标
主要结局
Progression-Free Survival
时间窗: January 2009
次要结局
未报告次要终点