A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

Phase 3 Completed 405 enrolled Helsinn Healthcare SA PSI CRO · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

Timeline

Start: 2015-11
Primary completion: 2016-08
Completion: 2016-08

Publications

Schwartzberg L, Roeland E, Andric Z, Kowalski D, Radic J, Voisin D, Rizzi G, Navari R, Gralla RJ, Karthaus M. Phase III safety study of intravenous NEPA: a novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann Oncol. 2018 Jul 1;29(7):1535-1540. doi: 10.1093/annonc/mdy169.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Netupitant	Small molecule	300 mg	Oral
Subject	Palonosetron	Other / unclassified	0.25 mg	Intravenous
Subject	Palonosetron	Other / unclassified	0.5 mg	Intravenous
Subject	Pro-netupitant	Unknown	260 mg	Intravenous
Background	Dexamethasone	Small molecule	—	Oral

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

Summary

Timeline

Publications

Drugs

Indications