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

Information source: Radboud University
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting

Sponsored by: Radboud University

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

Overall contact:
David M. Burger, PharmD PhD, Phone: 255-7484-68553, Email: d.burger@akf.umcn.nl

Summary

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: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

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.

Eligibility

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

Criteria:

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

Locations and Contacts

David M. Burger, PharmD PhD, Phone: 255-7484-68553, Email: d.burger@akf.umcn.nl

UMCN St. Radboud, Nijmegen 6500 HB, Netherlands; Recruiting
D M Burger, Pharm D, PhD, Principal Investigator

University Medical Center Groningen, Groningen, Netherlands; Not yet recruiting
An Reyners
An Reyners, Principal Investigator

Additional Information

Starting date: March 2008
Ending date: December 2010
Last updated: July 21, 2009

Page last updated: October 19, 2009

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