An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib - Pharmacokinetics of Erlotinib Plus Ritonavir

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 19 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Patients treated with single agent erlotinib 150mg QD, without disease
•progression at the first regular response evaluation after treatment initiation
•or patients who may benefit from erlotinib treatment.
•- Age * 18 years
•- Accessible for repeated venipunctures
•- Ability to understand the study and give signed informed consent prior to
•beginning of protocol specific procedures

•- Concomitant use of medication(s) which could influence the pharmacokinetics
•of erlotinib within 14 days or five half-lives of the drug (whichever is
•shorter) before start of the study, consisting of (but not limited to)
•CYP3A4-inhibitors/inductors
•- Active uncontrolled infection or severe cardiac dysfunction (such as New York
•Heart Association Class III or IV cardiac disease, myocardial infarction within
•the last 6 months, unstable arrhythmias, or unstable angina)
•- Impaired hepatic function (total bilirubin > ULN or Child-Pugh A, B and C)
•- Woman who are pregnant or breast feeding
•- Progression on erlotinib at the latest regular response evaluation
•- Current smokers

发起方

Antoni van Leeuwenhoek Ziekenhuis