Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen.
Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)|
- Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
- at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
- Also at day 5 at the same time points blood samples will be taken.
- Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
|Estimated Study Completion Date:||September 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429754
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University (RUNMC)|