NCT03403712

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination (IV NEPA FDC) Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination (Akynzeo®) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide (AC) Chemotherapy in Women With Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intravenous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion \[test\] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination \[control\]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	fosnetupitant/ palonosetron	intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
DRUG	netupitant/palonosetron	oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
DRUG	dexamethasone	Oral dexamethasone (12 mg)

Timeline

• Start date: 2018-03-16
• Primary completion: 2018-09-19
• Completion: 2018-09-19
• First posted: 2018-01-19
• Last updated: 2020-06-01
• Results posted: 2020-04-15

Locations

40 sites across 2 countries: United States, Georgia

Regulatory

• FDA-regulated drug study