NCT00909740已完成1 期
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MEGF0444A, Administered Intravenously to Patients With Advanced Solid Tumors
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
- 30
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.
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
- •Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit
排除标准
- •Inadequate hematologic and organ function
- •Anti-cancer therapy within 4 weeks prior to initiation of study treatment
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
- •Active infection or autoimmune disease
- •Pregnancy (positive pregnancy test) or lactation
研究组 & 干预措施
1
Experimental
干预措施: MEGF0444A (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Days 1-21 of cycle 1
Incidence, nature, relatedness, and severity of adverse events
时间窗: Day 1 to study completion
次要结局
- Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution(Following administration of study drug)
研究者
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