Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients (ACE)

November 26, 2020 updated by: Radboud University Medical Center

A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Cisplatin - Etoposide (CE) Treatment of Patients With Metastatic Lung Carcinoma (ACE).

The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Aprepitant acts initially as a moderate inhibitor of CYP3A4 followed by a short period of CYP3A4 induction. Etoposide is a substrate of CYP3A4 and may therefore be suvject to a drug interaction with aprepitant.

CE can be classified as a highly emetogenic chemotherapeutic regimen and the use of aprepitant may therefore be considered when no clinically relevant drug interaction with etoposide can be determined.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Nijmegen, Netherlands
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 18 and 75 years of age
  • able and willing to sign informed consent form
  • indication for treatment with CE regimen
  • subject is expected to receive at least 2 cycles of CE regimen
  • able to swallow capsules

Exclusion Criteria:

  • history of sensitivity/idiosyncrasy to aprepitant or excipients
  • condition that might interfere with drug absorption, distribution metabolism or excretion.
  • history or current abuse of drugs, alcohol or solvents
  • inability to understand the nature and extent of the trial and procedures
  • participation in a drug trial within 30 days prior to the first dose
  • febrile illness within 3 days before the first dose
  • concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
  • abnormal liver or renal function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Aprepitant 125mg oral on day 1 and 80mg on day 2 and 3 during CE treatment.
Drug: aprepitant
125mg on Day 1; 80mg on Day 2-3 during CE cycle. Dexamethasone is added as well.
Other Names:
  • Emend
Active Comparator: B
CE cycle with standard anti-emetic regimen.
Drug: Dexamethasone and Ondansetron during CE-treatment
Standard anti-emetic regimen during CE treatment
Other Names:
  • Decadron
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma concentrations of etoposide will be measured
Time Frame: just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3
just before etoposide infusion, at 0.5, 1,4,6,8 and 24 hours and 32 hours after dosing on study days 1 and 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Nausea and emetic episodes are recorded
Time Frame: Day 1,3,5 and 8 of each cycle
Day 1,3,5 and 8 of each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 24, 2007

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN-AKF 07.02
  • EudraCTnr 2007-003347-73

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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