NCT00327223已完成1 期
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
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
- 18
- 试验地点
- 4
- 主要终点
- Determine the maximally tolerated dose
研究概览
简要总结
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated malignant disease of any type.
- •Prior treatment; at least one prior regimen required.
- •Able to perform the activities of daily living.
- •Off prior cancer therapy for at least 4 weeks.
- •If female, neither pregnant nor nursing.
- •Willing to use contraceptives to prevent pregnancy.
- •No other serious illnesses.
- •No other active malignancy.
- •No serious infections.
- •No other current drug therapy for the cancer.
- •Blood counts and blood chemistries in or near normal range.
- •Prior radiation is permitted.
排除标准
- •No active brain metastases.
研究组 & 干预措施
imexon
Experimental
Dose escalation of imexon
干预措施: imexon (Drug)
结局指标
主要结局
Determine the maximally tolerated dose
determine the pharmacokinetics
determine the toxicity of the drug on the designated schedule
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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