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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 Cancer

NCT03403712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2020-06-01

Study results available
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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.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

fosnetupitant/ palonosetron

intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination

DRUG

netupitant/palonosetron

oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination

DRUG

dexamethasone

Oral dexamethasone (12 mg)

Sponsors & Collaborators

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Helsinn Healthcare SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2018-09-19
Completion
2018-09-19
FDA Drug
Yes

Countries

  • United States
  • Georgia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403712 on ClinicalTrials.gov