Phenotyping study of the CYP3A4 activity in patients with prostate cancer versus male patients with other types of solid tumours with midazolam
- Conditions
- prostate cancer and other types of solid tumours10027655
- Registration Number
- NL-OMON51249
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
1. Male patients receiving anticancer treatment or supportive care within our
institute
• Group 1: histological or cytological proof of prostate cancer, for which the
treatment leads to castrate levels of testosterone, defined as <= 50 ng/dL (or <=
0.50 ng/mL or 1.73 nmol/L)
• Group 2: histological or cytological proof of cancer.
2. Considered fit for midazolam treatment as assessed by the treating physician.
3. Age >= 18 years.
4. Able and willing to give written informed consent.
5. Able and willing to undergo blood sampling for PK and pharmacogenetic
analysis.
6. Able and willing to comply with study restrictions and to remain at the
study center for the required duration.
7. Adequate bone marrow, hepatic and renal functions
1. Concomitant use of medication, herbs or food which could influence the
pharmacokinetics of midazolam within 14 days or five half-lives of the drug
(whichever is shorter) before start of the study, consisting of (but not
limited to) CYP3A4-inhibitors/inducers. In particularly, use of enzalutamide,
bicalutamide and dexamethasone is not allowed within 14 days before start of
the study. The use of prednisolone is allowed at a maximum daily dose of 10 mg.
2. Current smokers or patients who stopped smoking within 7 days before study
allocation
3. Cachexia as evaluated by a modified Glasgow Prognostic Score (mGPS) of 2:
albumin <35 g/L and CRP >= 10 mg/L
4. Patients with a known psychological or physical condition and/or expected
poor prognosis, which in the opinion of the investigator, contra-indicates
hospitalization and/or participation in the study for the individual patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the CYP3A4 activity in prostate cancer patients versus patients with<br /><br>other types of solid tumours, by use of a midazolam phenotyping test</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To measure plasma concentrations of midazolam<br /><br>- To determine metabolite pharmacokinetics of midazolam<br /><br>- Since polymorphisms in genes encoding for CYP3A4 can be important<br /><br>determinants in the pharmacokinetics of midazolam, single nucleotide<br /><br>polymorphisms in these genes will be assessed retrospectively<br /><br>- exploratory: to differentiate between hepatic and gastro-intestinal CYP3A4<br /><br>activity by comparison of oral and intravenous midazolam PK</p><br>