An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib - N19RER

Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 10 人开始时间: 2019年1月28日最近更新: 2022年1月10日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
入组人数: 10

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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•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 or stopped smoking within 7 days before study allocation

发起方