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Interferon-Alfa 9MU

Phase 3

Renal Cell Carcinoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 27, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment791

FDA Designations

No designations recorded

Clinical trial landscape

Interferon-Alfa 9MU · 1 trial · 1 indication

Phase 3 1
NCT00631371Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma SubjectsRenal Cell Carcinoma
COMPLETED791 Analytics
PHASE3COMPLETED
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS): Independent-Assessment
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

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.

Secondary Endpoints

Progression-Free Survival (PFS): Investigator-Assessment
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Overall Survival (OS)
Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
2ACTIVE_COMPARATORBevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW

Interventions

NameTypeDescription
BevacizumabDRUGBevacizumab 10 mg/kg intravenous (IV) q8wks
TemsirolimusDRUGTemsirolimus 25 mg IV weekly
Interferon-Alfa 9MUDRUGInterferon-Alfa 9MU SC TIW
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites172

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...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileColombiaCzechiaFranceGermanyHong KongHungaryIndiaItalyMalaysiaMexicoNetherlandsPolandPortugalRussiaSerbiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainTaiwanUkraineUnited Kingdom
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Frequently asked questions about Interferon-Alfa 9MU

What is Interferon-Alfa 9MU used for?

Interferon-Alfa 9MU is used for the treatment of renal cell carcinoma, a type of kidney cancer. It is being studied as part of a combination therapy regimen for patients with advanced disease. The drug is currently in Phase 3 clinical development.

Who makes Interferon-Alfa 9MU?

Interferon-Alfa 9MU is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with renal cell carcinoma.

What phase is Interferon-Alfa 9MU in?

Interferon-Alfa 9MU is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.

What clinical trials is Interferon-Alfa 9MU in?

Interferon-Alfa 9MU is being evaluated in a Phase 3 clinical trial registered under the identifier NCT00631371. This completed study compared the combination of bevacizumab plus temsirolimus versus bevacizumab plus Interferon-Alfa in patients with advanced renal cell carcinoma. The trial enrolled 791 participants across multiple countries.

How does Interferon-Alfa 9MU work?

Interferon-Alfa 9MU is a small molecule drug. Its specific molecular target has not been disclosed in the available information, so its exact mechanism of action is not described here. The drug is being studied for its potential to treat renal cell carcinoma.