Overview

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

Status:
Terminated
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
BB 1101
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Etoposide
Fosaprepitant
Ondansetron
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