Non-small cell lung cancer Niet-kleincellig longkanker
Conditions
Interventions
Patients will be treated with erlotinib 75mg QD the first 7 days of the study and start with ritonavir on 9 until day 15. PK measerment will take place at day 1 and day 15.
Sponsors
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)
Eligibility
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and Cmin | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of the highly potent CYP3A4 inhibitor ritonavir on the pharmacokinetics (PK) of erlotinib, measured as AUC0-24h, AUCmean, Cmax and Cmin | — |
Contacts
Public ContactNeeltje Steeghs
Nederlands Kanker Instituut
Outcome results
None listed