NCT00255489已完成1 期
A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- To characterize the safety profile of ZD 1839 in these patients
研究概览
简要总结
The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Provision of written informed consent
- •Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
- •Histologically or cytologically conformed non-small cell lung cancer
- •Aged 18 or over
排除标准
- •Previous thoracic radiotherapy
- •Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
- •Known hypersensitivity to any component of study medication
结局指标
主要结局
To characterize the safety profile of ZD 1839 in these patients
次要结局
- To measure the quality of life compared to baseline
- To measure the change in disease related symptoms compared to baseline
研究者
研究点 (2)
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