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

January 25, 2016 updated by: Radboud University Medical Center

A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: aprepitant
Aprepitant treatment
Drug: Aprepitant

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: David M. Burger, PharmD PhD, Radboud University (RUNMC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

September 1, 2008

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN-AKF 06.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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