An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib (N19RER)
- Conditions
- on-small cell lung cancer Niet-kleincellig longkanker
- Registration Number
- NL-OMON22639
- Lead Sponsor
- The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
?1. Patients treated with single agent erlotinib 150mg QD for at least 4 weeks
?2. Age = 18 years
?3. Accessible for repeated venipunctures
?4. Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures
?1. 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
?2. 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)
?3. Impaired hepatic function (total bilirubin > ULN or Child-Pugh A, B and C)
?4. Woman who are pregnant or breast feeding
?5. Progression on erlotinib at the latest regular response evaluation
?5. Current smokers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and Cmin
- Secondary Outcome Measures
Name Time Method Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and Cmin