A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy
Status:
Withdrawn
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This is a phase III study designed to demonstrate the superiority of single-dose 90 mg
intravenous (IV) casopitant over placebo, each in combination with ondansetron and
dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase)
following initiation of the cisplatin infusion in the first cycle of highly emetogenic
chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their
first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day
1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral
dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral
dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose
90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.