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

NCT00429754 | Withdrawn Phase 4

• 1 other identifier: UMCN-AKF 06.01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nausea; Vomiting

Keywords

Nausea and vomiting after using cytostatic drugs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.

Study Arms (1)

aprepitant

OTHER

Aprepitant treatment

Drug: Aprepitant

Interventions

Aprepitant DRUG

aprepitant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David M. Burger, PharmD PhD

  Radboud University (RUNMC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Completion: September 1, 2008
• Last Updated: January 26, 2016

Record last verified: 2016-01