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Clinical trial

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

NCT03403712 is registered in ClinicalTrials.gov with Helsinn Healthcare SA as lead sponsor.

NCT NCT03403712
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Helsinn Healthcare SA
Phase
Phase 3
Overall status
Completed
Start date
March 16, 2018
Completion date
September 19, 2018
Enrollment
404 (actual)
Sites
40

Conditions

As the registry lists them; a condition with its own page is linked.

chemotherapy-induced nausea and vomiting