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