A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer

AstraZeneca2 个研究点分布在 1 个国家目标入组 36 人开始时间: 2004年5月最近更新: 2011年1月25日

适应症

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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

AstraZeneca

申办方类型

Industry

研究点 (2)

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