Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
This study has been withdrawn prior to enrollment.
(change of study population and chemotherapeutic regimen)
Merck Sharp & Dohme Corp.
Information provided by:
First received: January 31, 2007
Last updated: January 25, 2016
Last verified: January 2016
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.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
| Estimated Study Completion Date:
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 (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429754
Merck Sharp & Dohme Corp.
||David M. Burger, PharmD PhD
||Radboud University (RUNMC)
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 31, 2007
||January 25, 2016
||Netherlands: Medical Ethics Review Committee (METC)
Keywords provided by Radboud University:
Nausea and vomiting after using cytostatic drugs
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 23, 2016
Signs and Symptoms, Digestive
Signs and Symptoms
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurokinin-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action