Onderzoek naar het effect van OATP1B blokkade op de stofwisseling van sorafenib (Nexavar®) bij volwassen patiënten met kanker.
Completed
- Conditions
- Solid tumors treated with sorafenib (Nexavar®) mono therapy.
- Registration Number
- NL-OMON23851
- Lead Sponsor
- Erasmus Medical Center; Department of Medical Oncology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
•Age ≥18 years;
•Histological/ cytological confirmed diagnosis of cancer treated with sorafenib monotherapy
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Pregnant or child nursing patients;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
- Secondary Outcome Measures
Name Time Method 1. To compare the incidence and severity of side effects of treatment with sorafenib in the absence and presence of rifampicin (interim-analysis after 4 patients).<br /><br>2. To study the influence of genetic polymorphisms in OATP1B involved in the metabolism of sorafenib.<br /><br>3. To assess the degree of CYP3A induction after administration of rifampicin for two days by measuring midazolam clearance.