Status:
WITHDRAWN
Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Nausea
Vomiting
Eligibility:
MALE
18-75 years
Phase:
PHASE4
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 det...
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 eme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00429754
End Date
September 1 2008
Last Update
January 26 2016
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