Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Highly emetogenic chemotherapy (HEC) Chemotherapy-Induced Nausea and Vomiting (CINV)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 942
Healthy volunteers: no

Brief summary:
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (\> 24-120 hours) complete response (CR) rate (defined as no emesis and no use of rescue medications) in subjects receiving highly emetogenic chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines

Detailed description:

Arms:
arm 1: APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC arm 2: Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1

Interventions: intervention 1: APF530 intervention 2: Ondansetron intervention 3: Ondansetron placebo intervention 4: APF530 placebo intervention 5: Fosaprepitant intervention 6: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol document: