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

Primary Purpose

Nausea, Vomiting

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Aprepitant

About this trial

This is an interventional treatment trial for Nausea focused on measuring Nausea and vomiting after using cytostatic drugs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

aprepitant

Arm Description

Aprepitant treatment

Outcomes

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.

Full Information

NCT ID

NCT00429754

First Posted

January 31, 2007

Last Updated

January 25, 2016

Sponsor

Radboud University Medical Center

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00429754

Brief Title

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

Official Title

A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Why Stopped

change of study population and chemotherapeutic regimen

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Radboud University Medical Center

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Vomiting

Keywords

Nausea and vomiting after using cytostatic drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aprepitant

Arm Type

Other

Arm Description

Aprepitant treatment

Intervention Type

Drug

Intervention Name(s)

Aprepitant

Primary Outcome Measure Information:

Title

Pharmacokinetic blood samples will be taken at day 2 at pre-dose,

Title

at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.

Title

Also at day 5 at the same time points blood samples will be taken.

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M. Burger, PharmD PhD

Organizational Affiliation

Radboud University (RUNMC)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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