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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

NCT03403712•Helsinn Healthcare SA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Cycle 1:
•1. Patient read, understood and signed the written informed consent before any study related activity, agreeing to participate in the study and to comply with study requirements.
•2. Female patient of at least 8 years of age.
•3. Histologically or cytologically confirmed breast cancer, including recurrent or metastatic.
•4. Naïve to moderately or highly emetogenic antineoplastic agents.
•5. Scheduled to receive at least 4 consecutive cycles of an AC combination regimen.
•Notes:
•1. additional not emetogenic, minimally or low emetogenic antineoplastic agents are permitted at any time after start of AC combination on Day 1.
•2. additional highly or moderately emetogenic antineoplastic agents are only allowed on Day 1 after the start of AC combination, provided their administration is completed within 6 hours from the start of the AC combination administration.
•6. ECOG Performance Status of 0 or 1.
+12 more criteria

Exclusion Criteria

•Cycle 1:
•1. Lactating patient.
•2. Current use of illicit drugs or current evidence of alcohol abuse.
•3. Scheduled to receive moderately or highly emetogenic antineoplastic agent in addition to the AC regimen, from 6 hours after the start of the AC chemotherapy on Day 1 and up to Day 1 of Cycle 2.
•4. Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of AC chemotherapy administration on Day 1 or between Days 1 to 5, inclusive.
•5. Any vomiting, retching, or nausea (grade 1 as defined by National Cancer Institute) within 24 hours prior to the start of AC chemotherapy administration on Day 1.
•6. Symptomatic primary or metastatic central nervous system (CNS) malignancy.
•7. Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting \[CINV\]) or pose unwarranted risks in administering the study drugs to the patient.
•8. Known hypersensitivity or contraindication to 5 hydroxytryptamine type 3 (5-HT3) receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron), to dexamethasone, or to neurokinin-1 (NK1) receptor antagonists (e.g., aprepitant, rolapitant).
•9. Known contraindication to the IV administration of 50 mL 5% glucose solution.
+31 more criteria

Locations (40)

The Oncology Inst. Of Hope and Innovation

Tucson, Arizona, United States

Carti Cancer Center

Little Rock, Arkansas, United States

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

CBCC Global Research, INC at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

The Oncology Tnstitute of Hope and Innovation

Corona, California, United States

Uptimum Medical Group Inc.

Inglewood, California, United States

The Oncology Institute of Hope and Innnovation

Long Beach, California, United States

Hao Wei Zhang M.D.

Los Angeles, California, United States

Emad Ibrahim, MD, INC.

Redlands, California, United States

Watson Clinic LLP

Lakeland, Florida, United States

Key Dates

Start Date

March 16, 2018

Primary Completion Date

September 19, 2018

Completion Date

September 19, 2018

Last Updated

June 1, 2020

Enrollment

404

ACTUAL participants

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

fosnetupitant/ palonosetron

DRUG

netupitant/palonosetron

DRUG

dexamethasone

DRUG

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

NCT02106494

Chemotherapy-induced Nausea and Vomiting

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COMPLETEDPHASE3

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

NCT01937156

Chemotherapy-induced Nausea and Vomiting

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UNKNOWNPHASE2

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study