NCT00239291已完成1 期
A Phase I/II Study of ZD1839 (Iressa) Given Concurrently With Radiotherapy in Patients With Non-Metastatic Prostate 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
- 42
- 试验地点
- 1
- 主要终点
- Part A: Safety (incidence of DLTs)
研究概览
简要总结
To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer
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
- •Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
- •PSA below 20 ng/mL
- •Lymph node negative
- •Non-metastatic
- •Written informed consent
排除标准
- •Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
- •Distant or nodal metastases
- •Prostatectomy
- •Concomitant LHRH analog treatment
- •Previous or concomitant anti-androgens
- •Active ILD
结局指标
主要结局
Part A: Safety (incidence of DLTs)
Part B: Tolerability
次要结局
- EGFR-1 expression and activation status (autophoshorylation; p-EGFR-1) at diagnosis
研究者
研究点 (1)
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