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SU014813

Phase 2

Breast Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 17, 2011

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 Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00322517Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast CancerPHASE2 COMPLETED 90 — — Apr 1, 2006Jul 1, 2009May 17, 201122 United States, Germany +3
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Study Endpoints
Primary Endpoints
To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
June 2008
Secondary Endpoints
To assess onset and duration of tumor control and 1-year survival rate
AUG 2008
To evaluate the safety of SU-014813To assess patient reported outcomes
AUG 2008
To determine SU-014813 plasma trough concentration (Ctrough)
AUG 2008
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SU014813EXPERIMENTAL -
Interventions
NameTypeDescription
SU014813DRUG100 mg capsule/day for 6 cycle of 21 days
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent. * Must have received prior treatment with an anthracycline and a taxane either concurrently or se...

Countries:United StatesGermanyItalyNetherlandsUnited Kingdom
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