A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.

Phase 3 Completed 710 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindSupportive care

Summary

This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.

Timeline

Start: 2008-03-10
Primary completion: 2009-04-13
Completion: 2009-04-13

Outcome

Missed primary endpoint

registry Placebo vs Casopitant 90 mg; p = 0.7273; difference in percentage of participants 1.0 (95% CI -4.6 to 6.6) NCT00601172 ↗

Publications

Background Hesketh PJ, Wright O, Rosati G, Russo M, Levin J, Lane S, Moiseyenko V, Dube P, Kopp M, Makhson A. Single-dose intravenous casopitant in combination with ondansetron and dexamethasone for the prevention of oxaliplatin-induced nausea and vomiting: a multicenter, randomized, double-blind, active-controlled, two arm, parallel group study. Support Care Cancer. 2012 Jul;20(7):1471-8. doi: 10.1007/s00520-011-1235-4. Epub 2011 Aug 7.

Drugs

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