An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy

AstraZeneca1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2003年12月1日最近更新: 2009年4月23日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: AstraZeneca
入组人数: 30
试验地点: 1
主要终点: PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)

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

To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure

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: Male
接受健康志愿者: 否

入选标准

•Relapsed prostate cancer after prostatectomy or radiotherapy
•PSA levels below 10 ng/mL
•Lymph node negative
•Metastasis negative
•Withdrawal of hormone therapy at least 6 months before entry into the study
•Written informed consent

排除标准

•Metastatic disease
•Hormonal treatment 6 months before study entry
•Concomitant radiotherapy, surgery and/or chemotherapy

结局指标

主要结局

PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements)

次要结局

TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs)
Duration of PSA response
PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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