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leflunomide

Phase 3

Brain and Central Nervous System Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 13, 2012

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00003293SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma MultiformePHASE3 COMPLETED -Feb 1, 1998May 1, 2001Sep 11, 201235 United States, Canada
NCT00003775Leflunomide in Treating Patients With Anaplastic Astrocytoma in First RelapsePHASE2 COMPLETED 60Dec 1, 1998May 1, 2006Sep 13, 201226 United States, Canada
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Study Design & Arms
AllocationRANDOMIZED
PurposeTREATMENT
Interventions
NameTypeDescription
leflunomideDRUG -
procarbazine hydrochlorideDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

DISEASE CHARACTERISTICS: Histologically proven refractory or recurrent supratentorial glioblastoma multiforme Bidimensionally measurable, enhancing residual disease by T1-weighted gadolinium-enhanced MRI required within 15 days prior to treatment Stable dose of corticosteroids required for at least ...

Countries:United StatesCanada
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