cancer
Conditions
Interventions
Injection of a 100 microgram imatinib-d8 microdose
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic cancer; 2. On imatinib treatment at a stable dose of 400 mg once daily in the morning for at least 7 days (steady state plasma concentration) 3. Age >= 18 years; 4. Able and willing to give written informed consent; 5. WHO performance status of 0, 1 or 2; 6. Able and willing to undergo blood sampling for PK analysis;
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, ketoconazol, ritonavir and voriconazol), inhibitors of Pgp (e.g. ciclosporine, kinidine and verapamil), inhibitors of BCRP (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP; 3. Woman who are pregnant or breast feeding; 4. Patients suffering from any known disease or dysfunction that might influence the dissolution and/or absorption of imatinib (e.g. inflammatory bowel disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the absolute bioavailability of imatinib (Glivec®) at steady state after concomitant administration of a single 100 µg microdose of imatinib-d8 | — |
Countries
Netherlands
Outcome results
None listed