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

January 31, 2007
May 20, 2008
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  • 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.
Same as current
Complete list of historical versions of study NCT00429754 on ClinicalTrials.gov Archive Site
Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
Same as current
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Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nausea
  • Vomiting
Drug: Aprepitant
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2008
Not Provided

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
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00429754
UMCN-AKF 06.01
No
Not Provided
Radboud University
Merck Sharp & Dohme Corp.
Principal Investigator: David M. Burger, PharmD PhD Radboud University (RUNMC)
Radboud University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP