NCT02904850Unknown不适用
Validation of a Kinetic Model of Erlotinib
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference between plasma concentrations of erlotinib concentrations observed and predictive model
研究概览
简要总结
Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen
- •Age> 18 years
- •Subject has signed an informed consent
- •Treatment initiated for at least 7 days or dosage changed for at least 7 days
排除标准
- •Contraindication to the use of drug
- •Subject to exclusion period (as determined by a previous study or in progress)
- •Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)
- •Subject under judicial protection
- •Subject under tutorship or curatorship
- •Pregnancy (and woman of childbearing age without contraception)
- •Breastfeeding
结局指标
主要结局
Difference between plasma concentrations of erlotinib concentrations observed and predictive model
时间窗: 1 year
次要结局
- Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)(1 year)
研究者
研究点 (1)
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