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

This study has been terminated.
(change of study population and chemotherapeutic regimen)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00429754
First received: January 31, 2007
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Nausea
Vomiting
Drug: Aprepitant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Estimated Enrollment: 20
Estimated Study Completion Date: September 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429754

Sponsors and Collaborators
Radboud University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: David M. Burger, PharmD PhD Radboud University (RUNMC)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00429754     History of Changes
Other Study ID Numbers: UMCN-AKF 06.01
Study First Received: January 31, 2007
Last Updated: May 20, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Nausea and vomiting after using cytostatic drugs

Additional relevant MeSH terms:
Carcinoma
Nausea
Vomiting
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014