NCT00234442终止2 期
A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Disease control rate (complete response, partial response and stable disease)
研究概览
简要总结
The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC
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
- •Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
- •No symptoms due to brain metastases
- •No previous radiotherapy treatment for the Brain metastases
排除标准
- •No prior chemotherapy
- •No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
结局指标
主要结局
Disease control rate (complete response, partial response and stable disease)
次要结局
- Duration of response
- Time to progression
- Overall Survival
研究者
研究点 (4)
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