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SU011248; Capecitabine

Phase 1

Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 3, 2010

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
UNCONTROLLED
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00618124A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered TogetherPHASE1 COMPLETED 77May 1, 2005Jul 1, 2008May 3, 20103 United States
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Study Endpoints
Primary Endpoints
To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.
From Screening until disease progression or discontinuation of the study
Secondary Endpoints
To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered
From Cycle 1, Day 1 until discontinuation of the study
To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease
From screening until disease progression or discontinuation of the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
Interventions
NameTypeDescription
SU011248; CapecitabineDRUGDose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists * Patient has good performance status (ECOG 0 or 1) Exclusion Criteria: * Prior treatment with either SU011248 or capecitabine. * Hypertension that c...

Countries:United States
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