Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy

Phase 3 Completed 1140 enrolled Taiho Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.

Timeline

Start: 2006-07
Primary completion: 2007-05
Completion: 2007-08

Outcome

Met primary endpoint

paper 315 of 555 patients (56.8%) had complete response in the palonosetron group compared with 249 of 559 patients (44.5%) PMID 19135415 ↗

paper in the granisetron group (p<0.0001). PMID 19135415 ↗

Publications

Results Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol. 2009 Feb;10(2):115-24. doi: 10.1016/S1470-2045(08)70313-9. Epub 2009 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Granisetron	Other / unclassified	40 ug/kg	Intravenous
Subject	Palonosetron	Other / unclassified	0.75 mg	Intravenous