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Isovorin

Phase 3

Colon Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 13, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment650
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00195585Study Evaluating Isovorin in Colon CancerPHASE3 COMPLETED 650Oct 1, 2002Feb 1, 2006Aug 13, 20091 Japan
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Study Endpoints
Primary Endpoints
Relapse-free survival time
Secondary Endpoints
Disease-free survival time, survival time, safety
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
IsovorinDRUG -
UFTDRUG -
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Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Dukes C, Cure A colon cancer diagnosed histologically or cytologically * Normal organ function of bone marrow, heart, liver and kidney * Age 20-75 Other inclusion applies Exclusion Criteria: * Serious bone marrow suppression, infection, heart disease or complication * Famil...

Countries:Japan
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