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Ad.hIFN-β

Phase 1

Colorectal Carcinoma | Small molecule | Oncology |Biogen Inc.|Last Updated: Jul 14, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00107861Interferon-Beta Gene Transfer (Ad.hIFN-β) as Treatment for Refractory Colorectal Carcinoma With Liver MetastasesPHASE1 COMPLETED 44 — — May 1, 2005Sep 1, 2006Jul 14, 20092 United States
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Study Endpoints
Primary Endpoints
- Evaluate the safety of a single IV administration of Ad.hIFN-β.
Secondary Endpoints
Evaluate the MTD or maximum feasible dose (MFD) of Ad.hIFN-β.
Evaluate IFN-β and Ad.hIFN-β vector serum concentrations.
Evaluate immunogenicity of Ad.hIFN-β by measuring human anti adenovirus and human anti-IFN-β antibody formation.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Ad.hIFN-β (BG00001, IDEC-201)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects with histologically confirmed hepatic metastases from primary colorectal carcinoma. * Not amenable to complete surgical resection for attempted cure as determined by the Principal Investigator (PI). * Tumor progression after prior therapy for colorectal carcinoma, inc...

Countries:United States
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