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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02106494 | A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC | PHASE3 | COMPLETED | 942 | — | — | Mar 1, 2014 | May 1, 2015 | Mar 2, 2026 | 7 | United States |
Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.
| Arm | Type | Description |
|---|---|---|
| APF530 500 mg SC | EXPERIMENTAL | APF530 500 mg (granisetron 10 mg) SC and ondansetron placebo IV (0.15 mg/kg) and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 in association with HEC |
| ondansetron 0.15 mg/kg IV | ACTIVE_COMPARATOR | Ondansetron 2 mg/mL solution to be administered at 0.15 mg/kg IV (up to a maximum of 16 mg) and APF530 placebo SC and fosaprepitant 150 mg IV and dexamethasone 12 mg IV on Day 1 of Cycle 1 |
| Name | Type | Description |
|---|---|---|
| APF530 | DRUG | - |
| Ondansetron | DRUG | - |
| Ondansetron placebo | DRUG | - |
| APF530 placebo | DRUG | - |
| Fosaprepitant | DRUG | - |
| Dexamethasone | DRUG | - |
Inclusion Criteria: * Subjects will be males or nonpregnant females who are 18-87 years of age at the time of enrollment. * Subjects must have histologically or cytologically confirmed malignant disease. * Subjects must be undergoing treatment with a HEC regimen according to the 2011 ASCO CINV guid...