BioMed Research International / 2015 / Article / Tab 2 / Review Article
A Review of NEPA, a Novel Fixed Antiemetic Combination with the Potential for Enhancing Guideline Adherence and Improving Control of Chemotherapy-Induced Nausea and Vomiting Table 2 NEPA study designs.
Study Study design Patient population/chemotherapy Treatment groups Single versus multiple cycle Study objective Study 1 Hesketh et al. [33 ]Double-blind, randomized, dose-ranging, parallel group Phase 2 ( ) Chemotherapy-naïve Cisplatin-based chemotherapy (HEC) NEPA100 + DEX NEPA200 + DEX NEPA300 + DEX Oral PALO + DEX APR + IV OND + DEX (included as exploratory) Single cycle Identify best dose of NETU + PALO; demonstrate superiority of NEPA over oral PALO Study 2 Aapro et al. [34 ] Double-blind, randomized, parallel group Phase 3 ( ) Chemotherapy-naïve Anthracycline-cyclophosphamide NEPA + DEX Oral PALO + DEX Multiple cycle Demonstrate superiority of NEPA over oral PALO Study 3 Gralla et al. [35 ]Double-blind, randomized 3 : 1, parallel group Phase 3 ( ) Chemotherapy-naïve Any HEC or MEC (except AC) NEPA + DEX APR + oral PALO + DEX (3 : 1 randomization) Multiple cycle Demonstrate multiple cycle safety and describe efficacy of NEPA
HEC: highly emetogenic chemotherapy; MEC: moderately emetogenic chemotherapy; AC: anthracycline cyclophosphamide; DEX: dexamethasone; PALO: palonosetron; NETU: netupitant; APR: aprepitant; OND: ondansetron; NEPA100 : NETU 100 mg + oral PALO 0.50 mg; NEPA200 : NETU 200 mg + oral PALO 0.50 mg; NEPA300 : NETU 300 mg + oral PALO 0.50 mg; IV: intravenous.