Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)

This study has been terminated.

( change of study population and chemotherapeutic regimen )

First Received: January 31, 2007 Last Updated: May 20, 2008 History of Changes

Sponsors and Collaborators:	Radboud University Merck
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00429754

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 IV

MedlinePlus related topics: Nausea and Vomiting Testicular Disorders

Drug Information available for: Aprepitant

U.S. FDA Resources

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)

Further study details as provided by Radboud University:

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 Enrollment:	20
Estimated Study Completion Date:	September 2008

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 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429754

Sponsors and Collaborators

Radboud University

Merck

Investigators

Principal Investigator:

David M. Burger, PharmD PhD

Radboud University (RUNMC)

More Information

No publications provided

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)

Keywords provided by Radboud University:

Nausea and vomiting after using cytostatic drugs

Study placed in the following topic categories:

Vomiting
Signs and Symptoms, Digestive
Testicular Diseases
Antiemetics
Etoposide phosphate
Bleomycin
Carcinoma

Signs and Symptoms
Cisplatin
Nausea
Peripheral Nervous System Agents
Etoposide
Aprepitant

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009