NCT00977067终止1 期
A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 主要终点
- Incidence and nature of dose-limiting toxicities
研究概览
简要总结
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
干预措施: GDC-0152 (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities
时间窗: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
时间窗: Through study completion or early study discontinuation
次要结局
- Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance)(Through study completion or early study discontinuation)
研究者
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