Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
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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) |
- 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.
- 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 |
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 |
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 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 May 22, 2013