Recent Updates
Recently added Catalysts

Interferon Alfa

Phase 3

Carcinoma, Renal Cell | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 25, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,376

FDA Designations

No designations recorded

Clinical trial landscape

Interferon Alfa · 2 trials · 2 indications

Phase 3 2
NCT00083889SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell
COMPLETED750 Analytics
NCT00065468Study Evaluating Interferon And CCI-779 In Advanced Renal Cell CarcinomaCarcinoma, Renal Cell
COMPLETED626 Analytics
PHASE3COMPLETED
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Carcinoma, Renal CellUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Carcinoma, Renal CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS), Core Radiology Assessment
Day 28 of each 6-week cycle: duration of treatment phase

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 (PFS), Investigator's Assessment
Day 28 of each 6-week cycle: duration of treatment phase

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 (OS)
Baseline up to Month 80

Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Secondary Endpoints

Objective Response, Core Radiology Assessment
Day 28 of each 6-week cycle: duration of treatment phase
Objective Response, Investigator's Assessment
Day 28 of each 6-week cycle: duration of treatment phase
Overall Survival (OS)
Clinic visit or telephone contact every 2 months until death
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2ACTIVE_COMPARATOR -
1EXPERIMENTAL -
AACTIVE_COMPARATOR -
BEXPERIMENTAL -
CEXPERIMENTAL -

Interventions

NameTypeDescription
Interferon-alfaDRUG3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
SU011248DRUG50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Interferon AlfaDRUGInterferon 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-779DRUG25 mg of CCI-779 given Intra Venously once per week
Interferon Alfa and CCI-779DRUG15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites123

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...

Countries:United StatesAustraliaBrazilCanadaFranceGermanyItalyPolandRussiaSpainUnited KingdomArgentinaCzechiaGreeceHungaryLatviaLithuaniaMexicoNetherlandsSerbia and MontenegroSerbiaSlovakiaSouth AfricaSwedenTaiwanTurkey (Türkiye)Ukraine
Unlock Eligibility Criteria

Frequently asked questions about Interferon Alfa

What is Interferon Alfa used for in Carcinoma, Renal Cell?

Interferon Alfa is used for the treatment of Carcinoma, Renal Cell, also known as renal cell carcinoma. It has been evaluated in Phase 3 clinical trials as a therapy for this condition, including in patients with metastatic renal cell carcinoma.

Who makes Interferon Alfa?

Interferon Alfa is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is being studied for use in oncology, specifically for renal cell carcinoma.

What phase is Interferon Alfa in?

Interferon Alfa is in Phase 3 clinical development. It has completed two Phase 3 trials, and it remains an investigational drug, meaning it is still in clinical development and has not been approved for use.

What clinical trials is Interferon Alfa in?

Interferon Alfa has been studied in two completed Phase 3 trials. One trial, NCT00065468, evaluated Interferon and CCI-779 in advanced renal cell carcinoma with 626 participants. Another trial, NCT00083889, compared SU011248 versus Interferon-Alfa as first-line therapy for metastatic renal cell carcinoma with 750 participants.

Is Interferon Alfa the same as other drugs?

Interferon Alfa is a distinct drug entity. It has been compared against other agents in clinical trials, such as CCI-779 and SU011248, but it is not the same as those drugs. No alternative names for Interferon Alfa have been established.