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Safety and Efficacy of IV Pro-netupitant/Palonosetron for CINV Prevention
NCT02517021Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2015
- Primary completion
- Aug 2016
- Countries
- 12
- Sponsor
- Helsinn
- Modality
- Peptides, Small Molecules
- Conditions
- chemotherapy-induced nausea and vomiting (CINV)
01
Overview
Phase 3, randomised, double-blind trial of fosnetupitant + palonosetron in chemotherapy-induced nausea and vomiting (CINV) (2 arms), sponsored by Helsinn. Primary endpoint: Percentage of Patients With Adverse Events up to 14 weeks. Started Nov 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
IV NEPA + Dex
Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) + Dexamethasone
Oral NEPA + Dex
Oral Netupitant/Palonosetron (300 mg/0.50 mg) + Dexamethasone
03
Who it enrols
Adult patients with solid tumors naive to cytotoxic chemotherapy scheduled to receive at least 4 repeated consecutive cycles of highly emetogenic chemotherapy (HEC).
04
Endpoints
Primary
Percentage of Patients With Adverse Events
Secondary
Percentage of Patients With Complete Response (CR) in the Acute Phase
Percentage of Patients With Complete Response (CR) in the Delayed Phase
Percentage of Patients With Complete Response (CR) in the Overall Phase
Percentage of Patients With no Emetic Episodes in the Acute Phase
Percentage of Patients With no Emetic Episodes in the Delayed Phase
Percentage of Patients With no Emetic Episodes in the Overall Phase
Percentage of Patients With no Significant Nausea During the Acute Phase
Percentage of Patients With no Significant Nausea During the Delayed Phase
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