NCT00708006已完成1 期
A Phase 1 Dose-Escalation Study to Evaluate the Safety and Tolerability of HGS1029 (AEG40826-2HCl) in 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
- 66
- 试验地点
- 3
- 主要终点
- To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of HGS1029 in subjects with advanced solid tumors and to determine a phase 2 dose.
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
- •Confirmed advanced solid malignancy
- •Life expectancy of at least 3 months
- •Age 18 years or older
- •Acceptable liver function
- •Acceptable renal function
- •Acceptable hematologic status
排除标准
- •Received investigational (not yet approved by a regulatory authority)agent within 4 weeks before enrollment.
- •Received non-investigational agent within 3 weeks before enrollment.
- •Progressive CNS involvement including the need of corticosteroids
- •Pregnant or breast-feeding women
- •Active, uncontrolled bacterial, viral, or fungal infections within 2 weeks of Cycle 1 Day 1
- •Known HIV infection
研究组 & 干预措施
1
Experimental
HGS1029
干预措施: HGS1029 (Drug)
结局指标
主要结局
To assess the safety and dose-limiting toxicity of HGS1029 administered weekly X 3, repeated every 4 weeks
时间窗: throughout the study
次要结局
- Determination of pharmacokinetic profile; evaluation of biomarkers; evaluation of possible anti-tumor activity(throughout the study)
研究者
研究点 (3)
Loading locations...
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