Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03403712

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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03403712
Study type Interventional
Source Helsinn Healthcare SA
Contact
Status Completed
Phase Phase 3
Start date March 16, 2018
Completion date September 19, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT04054193 - Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045) Phase 4
Recruiting NCT04430361 - the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy Phase 2
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Completed NCT02285647 - An Open-Label, Randomized, Pivotal, Bioequivalence Study of Oral and Intravenous Rolapitant Phase 1
Terminated NCT01874119 - Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma Phase 2
Completed NCT01757210 - A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients N/A
Completed NCT01442376 - Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients Phase 3
Withdrawn NCT00891761 - A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy Phase 3
Completed NCT01031498 - Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting Phase 2
Terminated NCT02519842 - Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044) Phase 3
Recruiting NCT03232541 - The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting N/A
Completed NCT02909478 - Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Phase 3
Terminated NCT03237611 - Low Dose Aprepitant for Patients Receiving Carboplatin Phase 2
Completed NCT03649230 - Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Not yet recruiting NCT02933099 - Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Phase 3
Completed NCT02557035 - An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting Phase 3
Completed NCT00787566 - Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting Phase 2
Completed NCT06121414 - Effectiveness of Laserpuncture and Standard Antiemetic on RINVR Scores in Adolescent Patients Undergoing Chemotherapy N/A
Completed NCT04918069 - Capsaicin to Prevent Delayed Chemotherapy Induced Nausea and Vomiting (CapCIN) Phase 2
Recruiting NCT05851625 - Efficacy of Ear Acupuncture in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients N/A