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Sponsors and Collaborators: |
Radboud University Merck |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00429754 |
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 |
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Nausea Vomiting |
Drug: Aprepitant |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP) |
Estimated Enrollment: | 20 |
Estimated Study Completion Date: | September 2008 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | UMCN-AKF 06.01 |
Study First Received: | January 31, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00429754 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Nausea and vomiting after using cytostatic drugs |
Vomiting Signs and Symptoms, Digestive Testicular Diseases Antiemetics Etoposide phosphate Bleomycin Carcinoma |
Signs and Symptoms Cisplatin Nausea Peripheral Nervous System Agents Etoposide Aprepitant |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Autonomic Agents Therapeutic Uses Physiological Effects of Drugs |
Gastrointestinal Agents Antiemetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Aprepitant |