Effects of omeprazole on the pharmacokinetics of irinotecan in cancer patients.
Completed
- Conditions
- Cancer.
- Registration Number
- NL-OMON28883
- Lead Sponsor
- Erasmus MC - Afdeling Interne Oncologie
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
1. Histological or cytological confirmed diagnosis of any form of (irresectable and/or metastatic) cancer, which is thought to be sensitive to irinotecan-treatment;
2. Age >= 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 Plasma pharmacokinetics (PK) of irinotecan and its metabolites.
- Secondary Outcome Measures
Name Time Method 1. Side effects, especially neutropenia and late-onset diarrhea; <br /><br>2. Hepatic CYP3A activity, as determined by the intravenous midazolam hydroxylation test.