An Open-Label, Phase II Trial Of 250 mg ZD1839 (IRESSA™) In Prostate Cancer Patients With Early Biochemical Failure Post Prostatectomy

AstraZeneca4 个研究点分布在 1 个国家目标入组 80 人开始时间: 2003年1月1日最近更新: 2013年2月5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: 80
试验地点: 4
主要终点: The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

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

This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.

研究设计

研究类型: Interventional
分配方式: 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

•Removal of prostate for prostate cancer
•Raised level of prostate specific antigen (PSA) post-surgery
•Can have received some radiation therapy

排除标准

•Any after surgery male hormone blocking therapy.
•Low white blood cell count
•Abnormal liver function test

结局指标

主要结局

The primary objective of the trial is to evaluate the activity of oral ZD1839 (250 mg once daily administered continuously) in subjects with early biochemical failure post prostatectomy by estimating the PSA response rate

次要结局

To estimate the duration of PSA response
To estimate the partial PSA response rate
To estimate the change in the ratio of free PSA : total PSA at 6 and 12 months compared with baseline
To investigate the change in PSA levels after discontinuation of ZD1839

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

研究点 (4)

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