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

Information source: Radboud University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor

Intervention: aprepitant (Drug); Dexamethasone and Ondansetron during CE-treatment (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
David M. Burger, PharmD PhD, Principal Investigator, Affiliation: Radboud University


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

Etoposide chemotherapeutic regimen.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: plasma concentrations of etoposide will be measured

Secondary outcome: Nausea and emetic episodes are recorded

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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


- abnormal liver or renal function

Locations and Contacts

University Medical Center Groningen, Groningen, Netherlands

Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Additional Information

Starting date: March 2008
Last updated: March 1, 2010

Page last updated: August 20, 2015

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