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Also known as Roferon
Interferon Alfa · 2 trials · 2 indications
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...
Interferon Alfa is being studied in oncology for the treatment of renal cell carcinoma, also called kidney cancer. Both Phase 3 trials listed for this asset enrolled adults with metastatic renal cell carcinoma. It is given as a systemic therapy rather than as a localized treatment.
Interferon Alfa is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the two Phase 3 trials of the drug in renal cell carcinoma, including the study comparing SU011248 with Interferon-Alfa as first-line systemic therapy.
Interferon Alfa is in Phase 3 development for renal cell carcinoma. Both of its registered trials are Phase 3 studies, and both are now completed, with no active trials currently listed. It is an investigational therapy in this program rather than a newly approved product.
Two completed Phase 3 trials cover Interferon Alfa in renal cell carcinoma. NCT00083889 compared SU011248 with Interferon-Alfa as first-line systemic therapy in 750 patients. NCT00065468 evaluated Interferon combined with CCI-779 in advanced renal cell carcinoma in 626 patients. Together they enrolled 1,376 participants.
Both Interferon Alfa trials were randomized Phase 3 studies using active controls, and neither was double blinded. NCT00083889 enrolled 750 patients and NCT00065468 enrolled 626, for 1,376 participants total. Both studies required participants to be at least 18 years old and enrolled patients of all sexes.
Yes, Interferon Alfa and Interferon-alfa are the same agent, and the hyphenated spelling appears in the trial title for NCT00083889. Searches using either form refer to the same Pfizer Phase 3 program in renal cell carcinoma, so results and trial records apply to both names.