NCT00264446已完成1 期
Phase 1 Study of the Evaluation of Dihydropyrimidine Dehydrogenase (DPD), Uridine Phosphorylase (UP), Orotate Phosphoribosyl Transferase (OPRT), and Thymidine Phosphorylase (TP) Activity in Tissue Resected From Subjects Undergoing Planned Resection of Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection, Following Administration of Oral ADH300004 (Adherex Protocol Number AHX-03-101)
Adherex Technologies, Inc.2 个研究点 分布在 1 个国家开始时间: 2005年12月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will examine the kinetics of inhibition and recovery of the metabolic pathways for fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow optimization of oral 5 FU dosing to subjects in future studies.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •> or = 19 years of age
- •Patients with histologically confirmed:
- •primary or metastatic (known or suspected) colorectal carcinoma requiring planned surgical resection with hepatic biopsy and systemic chemotherapy , or
- •primary or metastatic neoplastic disease within the liver from any origin requiring planned surgical resection and systemic chemotherapy
- •Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing
排除标准
- •Lack of known or suspected metastatic disease in the liver
- •Known DPD deficiency
- •Severe infection
- •Inability to take oral medication
- •The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose
- •Stroke, major surgery, or other major tissue injury within 30 days before study entry
研究者
研究点 (2)
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