Overview

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cance

Status:
Completed

Trial end date:
2018-09-19

Target enrollment:

Participant gender:

Summary

Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion [test] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination [control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.

Phase:

Phase 3

Details

Lead Sponsor:

Helsinn Healthcare SA

Collaborators:

George Clinical Pty Ltd
PSI CRO AG
The Physicians' Services Incorporated Foundation

Treatments:

BB 1101
Dexamethasone
Dexamethasone acetate
Palonosetron