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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00083889 | SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma | PHASE3 | COMPLETED | 750 | — | — | Aug 1, 2004 | Sep 1, 2008 | Jan 26, 2010 | 123 | United States, Australia +9 |
| NCT00065468 | Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma | PHASE3 | COMPLETED | 626 | — | — | Jul 1, 2003 | Mar 1, 2011 | Oct 25, 2012 | 153 | United States, Argentina +24 |
Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.
Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.
Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
| Arm | Type | Description |
|---|---|---|
| 2 | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Interferon-alfa | DRUG | 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity |
| SU011248 | DRUG | 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity |
| Interferon Alfa | DRUG | Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter. |
| CCI-779 | DRUG | 25 mg of CCI-779 given Intra Venously once per week |
| Interferon Alfa and CCI-779 | DRUG | 15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week |
Inclusion Criteria: * Histologically confirmed renal cell carcinoma of clear cell histology with metastases * Evidence of measurable disease by radiographic technique * Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1 Exclusion Criteria: * Prior systemic (including adjuvan...