Phenotyping study of the CYP3A4 activity in patients with prostate cancer versus male patients with other types of solid tumours with midazolam - Phenotyping of CYP3A4 activity with Midazolam

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1. Male patients receiving anticancer treatment or supportive care within our
•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
•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
•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.

发起方

Antoni van Leeuwenhoek Ziekenhuis