NCT01579357已完成2 期
Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab
Arbeitsgemeinschaft medikamentoese Tumortherapie6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Influence of Cetuximab on metabolic activation of Capecitabine
研究概览
简要总结
The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •signed written informed consent
- •male or female > 18 years
- •K-ras wild type adenocarcinoma of the colon or rectum
- •metastatic colorectal carcinoma
- •ECOG <= 2
排除标准
- •brain metastasis
- •previous chemotherapy
- •stage 3 or 4 heart failure
- •uncontrolled angina
- •pregnancy or lactation
结局指标
主要结局
Influence of Cetuximab on metabolic activation of Capecitabine
时间窗: 9 weeks
Curve fitting of drug and metabolite concentrations will be performed. For pharmacokinetic modelling of CCB and metabolites, a non-compartment model for extravascular input will be used. For calculation of AUC and AUMC the linear trapezoid rule will be applied for the ascending part of the concentraion-time curve and the log-linear trapezoidal rule for the descending part of the concentration-time curve.
次要结局
未报告次要终点
研究者
研究点 (6)
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