NCT00519233已完成1 期
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
研究概览
简要总结
The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.
详细描述
Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.
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
- •Patient has hormone-refractory metastatic prostate cancer
排除标准
- •Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects
- •Patient is currently participating or has participated in an investigational study within the past 30 days
- •Patient has illness or circumstance that could limit compliance with the study requirements
- •Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year
- •Patient has Hepatitis B or C
研究组 & 干预措施
1.AGS-1C4D4
Experimental
干预措施: AGS-1C4D4 (Drug)
结局指标
主要结局
Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
时间窗: 3 Months
次要结局
- The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.(3 Months)
研究者
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