NCT00197431Unknown2 期
Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
Hamamatsu University1 个研究点 分布在 1 个国家开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 1
- 主要终点
- Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
研究概览
简要总结
S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with digestive organ cancer
排除标准
- •Patients without digestive organ cancer
结局指标
主要结局
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
次要结局
- Side effect and motility of patients treated with S-1
研究者
研究点 (1)
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