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BIIB015

Phase 1

Solid Tumors | Small molecule | Oncology |Biogen Inc.|Last Updated: Sep 16, 2013

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 Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00674947A Phase I Study of BIIB015 in Relapsed/Refractory Solid TumorsPHASE1 COMPLETED 55Jun 1, 2008Jun 1, 2011Sep 16, 20133 United States
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Study Endpoints
Primary Endpoints
To evaluate safety
ongoing
To determine the maximum-tolerated dose (MTD)
ongoing
Secondary Endpoints
To evaluate pharmacokinetics (PK)
ongoing
To evaluate clinical activity
ongoing
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
BIIB015DRUGIV infusion once every 3 weeks until disease progression or unacceptable toxicity
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria * Age 18 years or older at the time of informed consent. * Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists. * ECOG Performance Status \</= 2. Exclusion Criteria * History of keratoconjunctivi...

Countries:United States
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