Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
|ClinicalTrials.gov Identifier: NCT00429754|
Recruitment Status : Withdrawn (change of study population and chemotherapeutic regimen)
First Posted : February 1, 2007
Last Update Posted : January 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Nausea Vomiting||Drug: Aprepitant||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)|
|Estimated Study Completion Date :||September 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429754
|Principal Investigator:||David M. Burger, PharmD PhD||Radboud University (RUNMC)|