Interaction study of Docetaxel + Tolbutamide and Milk Thistle.
Recruiting
- Conditions
- Pharmacokinetic herb-drug interaction, cancer, docetaxel, milk thistle, tolbutamide Dutch: farmacokinetische interacties, kanker, docetaxel, mariadistel, tolbutamide
- Registration Number
- NL-OMON27803
- Lead Sponsor
- The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Patients for whom treatment with docetaxel is considered to be
of therapeutic benefit, e.g. advanced breast, gastric, esophagus,
bladder, ovarian cancer and non-small cell lung cancer, head and neck cancer and prostate cancer;
Exclusion Criteria
1. Any treatment with investigation drugs within 30 days before the start of the study;
2. Patients with known alcoholism, drug addiction and/or a psychiatric or physiological condition which in the opinion of the investigator would impair study compliance;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of docetaxel and tolbutamide on day 1 and 22: AUC, Cmax, t1/2.
- Secondary Outcome Measures
Name Time Method Safety parameters: (serious )adverse events.