Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater

• Patient is post menopausal or, if premenopausal, must use double-barrier contraception

Exclusion Criteria:

• Patient has symptomatic primary or metastatic CNS malignancy

• Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6

• Patient has vomited in the 24 hours prior to treatment Day 1

• Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse

• Patient is pregnant or breast feeding