cancer solid tumors
Conditions
Interventions
Patients will receive twice a 100 microgram dose of alectinib-d6 (microtracer).
The first dose will be administered with the standardized breakfast en de
second dose will be administered after a was
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Currently treated with alectinib for an oncological indication; 2. On alectinib treatment at a stable dose of 600 mg twice daily according to standard of care;
Exclusion criteria
Exclusion criteria: 1. Any treatment with investigational drugs within 30 days or 5 half-lives prior to receiving the investigational treatment; 2. Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, claritromycine, erytromycine, indinavir, itraconazol, ketoconazole, ritonavir and voriconazol), or inductors of CYP3A4 within two weeks or 5 half-lives prior to the start of the study. Alectinib is not a substrate for P-gp, BCRP, OATP1B1 or OATP1B3 [15]. 3. Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of alectinib (e.g. inflammatory bowel disease, gastric bypass).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the food-effect of the standardised breakfast on alectinib-d6 pharmacokinetics, the pharmacokinetic metrics will be analyzed with a Wilcoxin signed-rank test. | — |
Countries
Netherlands
Outcome results
None listed