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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00429754
• Other study ID #: UMCN-AKF 06.01
• Status: Withdrawn
• Phase: Phase 4
• First received: January 31, 2007
• Last updated: January 25, 2016
• Est. completion date: September 2008

Study information

• Verified date: January 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Aprepitant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
Primary	at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
Primary	Also at day 5 at the same time points blood samples will be taken.
Secondary	Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.