Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Phase 3 Completed 1840 enrolled GlaxoSmithKline

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Timeline

Start: 2006-07
Primary completion: 2007-10
Completion: 2009-10

Publications

Results Herrstedt J, Apornwirat W, Shaharyar A, Aziz Z, Roila F, Van Belle S, Russo MW, Levin J, Ranganathan S, Guckert M, Grunberg SM. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. J Clin Oncol. 2009 Nov 10;27(32):5363-9. doi: 10.1200/JCO.2009.21.8511. Epub 2009 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Casopitant	Small molecule	50 mg	Oral
Subject	Casopitant	Small molecule	90 mg	Oral
Subject	Casopitant	Small molecule	150 mg	Oral
Background	Dexamethasone	Small molecule	8 mg	Intravenous
Background	Ondansetron	Other / unclassified	8 mg	Oral

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

Summary

Timeline

Publications

Drugs

Indications