Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 404 | — | — | Mar 16, 2018 | Sep 19, 2018 | Jun 1, 2020 | 40 | United States, Georgia |
| Arm | Type | Description |
|---|---|---|
| Test group | EXPERIMENTAL | intravenous 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 group | ACTIVE_COMPARATOR | oral 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) |
| Name | Type | Description |
|---|---|---|
| fosnetupitant/ palonosetron | DRUG | intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination |
| netupitant/palonosetron | DRUG | oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination |
| dexamethasone | DRUG | Oral dexamethasone (12 mg) |
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...