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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00631371 | Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects | PHASE3 | COMPLETED | 791 | — | — | Apr 1, 2008 | Apr 1, 2015 | Apr 27, 2016 | 172 | United States, Argentina +28 |
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly |
| 2 | ACTIVE_COMPARATOR | Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab 10 mg/kg intravenous (IV) q8wks |
| Temsirolimus | DRUG | Temsirolimus 25 mg IV weekly |
| Interferon-Alfa 9MU | DRUG | Interferon-Alfa 9MU SC TIW |
Inclusion Criteria: * Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC) * Majority component of conventional clear-cell type is mandatory * At least 1 measurable lesion (per RECIST) Exclusion Criteria: * Prior systemic treatment for RCC * Evidence of curren...