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Interferon

Phase 2

Carcinoma, Renal Cell | Small molecule | Oncology |Bayer AG|Last Updated: Oct 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment189

FDA Designations

No designations recorded

Clinical trial landscape

Interferon · 1 trial · 1 indication

Phase 2 1
NCT00117637BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell
COMPLETED189 Analytics
PHASE2COMPLETED
BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
Carcinoma, Renal CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period
From randomization of the first subject until 15 months later, assessed every 8 weeks

Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

Secondary Endpoints

Progression-free Survival (PFS) Based on Investigator Assessment for the First Intervention Period
From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
Disease Control (DC) According to Independent Central Review for the First Intervention Period
From randomization of the first subject until 15 months later, assessed every 8 weeks
Disease Control (DC) According to the Investigator Assessment for the First Intervention Period
From randomization of the first subject until 3 years and 9 months later, assessed every 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
First Sorafenib (Nexavar, BAY43-9006) 400 mg then 600 mgEXPERIMENTALSubjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression (= first intervention period, 5.7 months \[median\] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months \[median\]) on a continuous basis.
First Interferon then Sorafenib (Nexavar, BAY43-9006) 400 mgACTIVE_COMPARATORInterferon (IFN) α-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months \[median\]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period.After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months \[median\]).

Interventions

NameTypeDescription
Sorafenib (Nexavar, BAY43-9006)DRUGMulti kinase inhibitor
InterferonDRUGInterferon
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice * Male or female patients \>= 18 years of age * Patients who have a life ...

Countries:United StatesFranceGermanyPolandRussiaUkraineUnited Kingdom
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Frequently asked questions about Interferon

What is Interferon used for in Carcinoma, Renal Cell?

Interferon is being studied for the treatment of unresectable and/or metastatic renal cell carcinoma, a type of kidney cancer. It is currently in Phase 2 clinical development as an investigational therapy for this condition.

Who makes Interferon?

Interferon is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker symbol BAYRY. The company is conducting clinical research to evaluate the drug's safety and efficacy in renal cell carcinoma.

What phase is Interferon in?

Interferon is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to assess its use in patients with renal cell carcinoma.

What clinical trials is Interferon in?

Interferon has been studied in a completed Phase 2 clinical trial with the identifier NCT00117637. This trial enrolled 189 patients with unresectable and/or metastatic renal cell carcinoma and compared Interferon against an active control treatment.

Is Interferon the same as BAY43-9006 (Sorafenib)?

No, Interferon is not the same as BAY43-9006 (Sorafenib). In the clinical trial NCT00117637, Interferon was compared against Sorafenib as an active control. Interferon is a separate investigational drug being evaluated for renal cell carcinoma.