Observational Study;Midazolam as CYP3A phenotyping probe to investigate the effects of lapatinib on hepatic CYP3A activity.
Recruiting
- Conditions
- 1. cancer<br />2. drug-drug interaction<br />3. CYP3A<br />4. lapatinib.
- Registration Number
- NL-OMON22273
- Lead Sponsor
- Erasmus MC-Daniel den HoedDepartment of Medical OncologyGroene Hilledijk 3013075 EA Rotterdamthe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Any patient who is going to be treated with lapatinib (1,250–1,500 mg once daily);
2. Age >= 18 years;
Exclusion Criteria
1. Symptomatic CNS-metastases or a history of a psychiatric disorder that would prohibit the understanding and giving of informed consent;
2. Use of and/or unwillingness to abstain from grapefruit, grapefruit juice, star fruit, dietary supplements, herbal tea, herbals, and over-the-counter medication (except for acetaminophen (paracetamol) and ibuprofen) during the study period, starting 3 weeks before the first midazolam hydroxylation test and ending after the third test;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CYP3A-activity, as determined by midazolam clearance tests.
- Secondary Outcome Measures
Name Time Method Auto-inhibition of lapatinib, as determined by lapatinib-levels.