NCT02136342终止1 期
Phase 1 Trial Evaluating Tolerability and Pharmacokinetics of Chlorogenic Acid for Injection in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of the study is to explore if chlorogenic acid is safe in patients with cancer.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •advanced cancer with no effective treatment
- •Karnofsky performance status no less than 70
- •adequated organ function
- •informed consent
排除标准
- •allergic to chlorogenic acid
- •persistent toxicities from previous treatment (no less than grade 2)
研究组 & 干预措施
chlorogenic acid
Experimental
干预措施: chlorogenic acid (Drug)
结局指标
主要结局
Number of adverse events
时间窗: within the first 60 days after the first dose of chlorogenic acid
次要结局
- Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of chlorogenic acid(within the first 30 days after the first dose of chlorogenic acid)
- improvement in cancer-related symptoms and quality of life(within 1 year after the first dose of chlorogenic acid)
- dose-limiting toxicity(within the first 30 days after the first dose of chlorogenic acid)
- maximum tolerated dose(within the first 30 days after the first dose of chlorogenic acid)
研究者
Shi Yuankai
Dr.
Chinese Academy of Medical Sciences
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