NCT00502164已完成1 期
A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced 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
- 40
- 试验地点
- 3
- 主要终点
- To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
研究概览
简要总结
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced 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
- •Men, 18yrs and older
- •Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
- •Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma
排除标准
- •Prior radiotherapy to bone metastases within 4 weeks prior to screening
- •any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
- •Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.
结局指标
主要结局
To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma
次要结局
- Explore the PK profile of AZD2171 at steady-state administration to subjects
研究者
研究点 (3)
Loading locations...
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