Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)

Study Overview
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Brief Summary
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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.

Detailed Description
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Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.

Official Title
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A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 75 years of age able and willing to sign Informed Consent Form subject has an indication for treatment with BEP regimen subject is expected to receive at least 2 cycles of BEP regimen subject is able to swallow capsules Exclusion Criteria: documented history of sensitivity/idiosyncrasy to aprepitant or excipients relevant history or condition that might interfere with drug absorption history of or current abuse of drugs, alcohol or solvents inability to understand nature and extent of the trial and the procedures participation in a drug trial within 30 days prior to the first dose febrile illness within 3 days before the first dose use of agents that are known to interfere with aprepitant pharmacokinetics abnormal liver or renal function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: aprepitant<br>Aprepitant treatment | Drug: Aprepitant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea and vomiting after using cytostatic drugs