A Phase Iii, Randomized, Double-Blind Study Of Single-Dose Intravenous Fosaprepitant In Preventing Chemotherapy-Induced Nausea And Vomiting Associated With Moderately Emetogenic Chemotherapy

9629 Background: This is the first study performed to directly evaluate the efficacy and safety of a single dose of intravenous (IV) fosaprepitant (FA), an NK1 receptor antagonist, used with a 5-HT3 antagonist and corticosteroid in subjects receiving moderately emetogenic chemotherapy (MEC). Methods: This was a global, phase 3, randomized, double-blind, parallel-group study in adult subjects naive to MEC and highly emetogenic chemotherapy (HEC) scheduled to receive an IV dose of ≥ 1 MEC agents on treatment day 1. Subjects were randomly assigned 1:1 to a control or FA regimen. Those in the control regimen received 8 mg oral ondansetron, 20 mg dexamethasone, and IV saline as placebo before the first dose of MEC on day 1, and 8 mg oral ondansetron 8 hours after the first dose, followed by 8 mg oral ondansetron every 12 hours on days 2 and 3. Those in the FA regimen received the same dose of oral ondansetron on day 1, along with 12 mg dexamethasone and a single dose of 150 mg IV FA before the first dose of ME...