A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

Phase 3 Completed 810 enrolled GlaxoSmithKline

RandomizedParallel-groupPrevention

Summary

This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.

Timeline

Start: 2006-11-06
Primary completion: 2007-10-09
Completion: 2007-10-09

Outcome

Met primary endpoint

paper 175 [66%] patients in the control group, 228 [86%] in the single-dose oral casopitant mesylate group [p<0.0001 vs control] PMID 19428297 ↗

Publications

Results Grunberg SM, Rolski J, Strausz J, Aziz Z, Lane S, Russo MW, Wissel P, Guckert M, Wright O, Herrstedt J. Efficacy and safety of casopitant mesylate, a neurokinin 1 (NK1)-receptor antagonist, in prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jun;10(6):549-58. doi: 10.1016/S1470-2045(09)70109-3. Epub 2009 May 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Casopitant	Small molecule	50 mg	Intravenous
Subject	Casopitant	Small molecule	150 mg	Intravenous
Background	Dexamethasone	Small molecule	—	Oral
Background	Ondansetron	Other / unclassified	—	Intravenous