Recent Updates
Recently added Catalysts

SU011248; Gemcitabine

Phase 1

Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 30, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00615446A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid TumorsPHASE1 COMPLETED 44Mar 1, 2005May 1, 2009Apr 30, 20103 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
From screening until at least 28 days beyond discontinuation of study treatment
Secondary Endpoints
To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered
From screening until at least 28 days beyond discontinuation of study treatment
To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease
From screening until at least 28 days beyond discontinuation of study treatment
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
Interventions
NameTypeDescription
SU011248; GemcitabineDRUGDose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity
Unlock Study Design Details
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 gemcitabine or SU011248 * Hypertension that can...

Countries:United States
Unlock Eligibility Criteria