Start Date
September 30, 2009
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
Dexamethasone
16 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
Dexamethasone
20 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
IV casopitant (placebo)
IV casopitant (placebo) administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study day 1.
IV casopitant (active)
Single-dose 90 mg IV casopitant administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study Day 1.
Ondansetron
32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1.
GSK Investigational Site, Tampa
GSK Investigational Site, Robbinsdale
GSK Investigational Site, Sherbrooke
Lead Sponsor
GlaxoSmithKline
INDUSTRY