Effects of rosuvastatin on the pharmacokinetics of imatinib.
- Conditions
- malignancysarcomagastrointestinal stromal tumour
- Registration Number
- NL-OMON21949
- Lead Sponsor
- Prof. Dr. J. VerweijErasmus MC - Daniel den Hoed Cancer CenterGroene Hilledijk 3013075 EA Rotterdam
- Brief Summary
Eechoute et al. Environmental and genetic factors affecting transport of imatinib by OATP1A2. Clin Pharmacol Ther. 2011;89(6):816-20
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1.Histological or cytological confirmed diagnosis of any form of irresectable and/or metastatic GIST, which is already treated with imatinib for a consecutive period of at least 4 weeks;
2.Age ³ 18 years;
Exclusion Criteria
1.Pregnant or lactating patients; patients with reproductive potential must use a reliable method of contraception (excluding oral contraceptives), if required;
2.Serious illness or medical unstable condition requiring treatment, symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To investigate the influence of rosuvastatin on the plasma pharmacokinetics of imatinib (and its metabolite CGP74588) in GIST cancer patients.
- Secondary Outcome Measures
Name Time Method -To correlate genetic polymorphisms in enzymes and drug transporting pumps [40,41] with imatinib pharmacokinetics and adverse effects in GIST cancer patients (according to METC protocol 02-1002).<br /><br>-To study possible side-effects due to the combination treatment of imatinib and rosuvastatin. <br><br>