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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02031991 | A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01) | PHASE1 | COMPLETED | 102 | — | — | Jan 1, 2014 | Aug 1, 2014 | Aug 15, 2014 | 1 | United States |
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| A = PF-06439535 | EXPERIMENTAL | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| B = Bevacizumab-EU | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| C = Bevacizumab-US | ACTIVE_COMPARATOR | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| Name | Type | Description |
|---|---|---|
| PF-06439535 | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
| Avastin | BIOLOGICAL | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
Inclusion Criteria: * Healthy male subjects 21-55 years old * Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug...