At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating fosnetupitant/ palonosetron, netupitant/palonosetron, and 1 other intervention for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 404 participants across 40 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
Oral dexamethasone (12 mg)