A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
18 Years
75 Years
Male
Nausea, Vomiting
Trial Information
A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
Principal Investigator
David M. Burger, PharmD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radboud University (RUNMC)
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
UMCN-AKF 06.01
NCT ID:
NCT00429754
Start Date:
Completion Date:
September 2008
Related Keywords:
- Nausea
- Vomiting
- Nausea and vomiting after using cytostatic drugs
- Carcinoma
- Nausea
- Vomiting
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