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SU-011,248

Phase 2

Kidney Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 7, 2007

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 Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00054886Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney CancerPHASE2 COMPLETED 63 — — Jan 1, 2003Aug 1, 2004May 7, 200715 United States
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Study Endpoints
Primary Endpoints
The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.
Secondary Endpoints
The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
SU-011,248DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer. * The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given. * Any side effects from prior therapy must have subsided, and blood and...

Countries:United States
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