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fosnetupitant/ palonosetron

Phase 3

Chemotherapy-induced Nausea and Vomiting | Small molecule | Other |Healthcare Services Group|Last Updated: Jun 1, 2020

Success Probability
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment404
FDA Designations
No designations recorded
Clinical trial landscape

fosnetupitant/ palonosetron · 1 trial · 1 indication

Phase 3 1
NCT03403712A 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 CancerChemotherapy-induced Nausea and Vomiting
COMPLETED404 Analytics
PHASE3COMPLETED
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
Chemotherapy-induced Nausea and Vomiting
NCT03403712404
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-emergent AEs at Cycle 1
At the end of Cycle 1 (each cycle is 21 days)
Number of Participants With Treatment-emergent AEs All Cycles
At the end of Cycle 4 (each cycle is 21 days)
Number of Participants With Severe (i.e., CTCAE Grade ≥3) TEAEs Reported for ≥2% of Patients in Either Treatment Group and Overall Throughout the Study
At the end of Cycle 4 (each cycle is 21 days)
Number of Participants With Study-Drug-Related TEAEs Reported for ≥2% of Patients in Either Treatment Group Throughout the Study
At the end of Cycle 4 (each cycle is 21 days)
Secondary Endpoints
Complete Response in Cycle 1 During the Acute Phase
24 hours after the start of AC chemotherapy administration
Complete Response in Cycle 1 During the Delayed Phase
120 hour after the start of AC chemotherapy administration
Complete Response in Cycle 1 During the Overall Phase
0-120 hours after the start of AC chemotherapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Test groupEXPERIMENTALintravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination, administered as a 30-minute infusion of a 50 mL solution, on Day 1 of each cycle. Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
Control groupACTIVE_COMPARATORoral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle. Oral dexamethasone will be administered on Day 1 of each cycle (12 mg)
Interventions
NameTypeDescription
fosnetupitant/ palonosetronDRUGintravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
netupitant/palonosetronDRUGoral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
dexamethasoneDRUGOral dexamethasone (12 mg)
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Eligibility Criteria
Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: Cycle 1: The following inclusion criteria must be checked prior to inclusion at Cycle 1: 1. Patient read, understood and signed the written informed consent before any study related activity, agreeing to participate in the study and to comply with study requirements. 2. Female...

Countries:United StatesGeorgia
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