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

Phase 4

Withdrawn

• Conditions: Nausea; Vomiting
• Interventions: Drug: Aprepitant

• Registration Number: NCT00429754
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Study Completion: 2008-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aprepitant	Aprepitant	Aprepitant treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.