Recent Updates
Recently added Catalysts

SU011248; Gemcitabine

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

SU011248; Gemcitabine · 1 trial · 1 indication

Phase 1 1
NCT00615446A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid TumorsSolid Tumors
COMPLETED44 Analytics
PHASE1COMPLETED
A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors
Solid TumorsUnlock trial analytics

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 to 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

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about SU011248; Gemcitabine

What is SU011248 used for?

SU011248 is an investigational small molecule being studied for the treatment of solid tumors. It is being evaluated in combination with gemcitabine in patients with advanced solid tumors. The drug is in Phase 1 clinical development and is not yet approved for any use.

Who is developing SU011248?

SU011248 is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of solid tumors.

What phase is SU011248 in?

SU011248 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of solid tumors and has not been approved by regulatory authorities. The drug is being evaluated in combination with gemcitabine.

What clinical trials is SU011248 in?

SU011248 has been studied in one clinical trial, identified as NCT00615446. This Phase 1 trial, titled "A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors," has been completed. The trial enrolled 44 participants in the United States.

Is SU011248 the same as gemcitabine?

No, SU011248 and gemcitabine are different drugs. SU011248 is an investigational small molecule being developed by Pfizer, while gemcitabine is a separate chemotherapy agent. In the clinical trial NCT00615446, the two drugs are being studied in combination for the treatment of advanced solid tumors.