Testicular Cancer
Conditions
Keywords
aprepitant, etoposide, pharmacokinetic interaction, CYP3A4, clinical relevant interaction, pharmacokinetics
Brief summary
Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4. Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP. Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.
Interventions
Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).
Sponsors
Radboud University Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with TC who will start or already started treatment with (B)EP * Age of at least 18 years * Patients from whom it is possible to collect blood samples * Patients who are able and willing to give written informed consent prior to screening
Exclusion criteria
* Patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong CYP3A4 inhibitor OR weak, moderate and strong inducers of CYP3A4 according to the table based on the Flockhart table (Appendix 1) less than 30 days prior to study or during the study. * Creatininclearance \<40 ml/min * Severe liver dysfunction (bilirubin\>ULN)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exposure to etoposide | 24 hours after administration | Etoposide exposure (AUC0-24hr) with and without cotreatment with aprepitant |
Countries
Netherlands
Outcome results
None listed