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.