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SU011248; Capecitabine

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

SU011248; Capecitabine · 1 trial · 3 indications

Phase 1 1
NCT00618124A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered TogetherSolid Tumors
COMPLETED77 Analytics
PHASE1COMPLETED
A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together
Solid TumorsUnlock trial analytics

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 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 SU011248 or capecitabine. * Hypertension that c...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about SU011248; Capecitabine

What is SU011248 and Capecitabine used for?

SU011248 and Capecitabine is an investigational combination of two small molecule drugs being studied for the treatment of solid tumors, including breast cancer and other neoplasms. The combination is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes SU011248 and Capecitabine?

SU011248 and Capecitabine is being developed by Pfizer, Inc., a biopharmaceutical company publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical research to evaluate the safety and tolerability of this drug combination.

What phase is SU011248 and Capecitabine in?

SU011248 and Capecitabine is in Phase 1 clinical development. This early-stage trial is designed to determine the best doses of the two drugs when administered together. The drug combination is investigational and has not been approved for any indication.

What clinical trials is SU011248 and Capecitabine in?

SU011248 and Capecitabine has one completed Phase 1 clinical trial registered as NCT00618124, titled 'A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together.' The trial enrolled 77 participants in the United States and was not randomized or blinded.

Is SU011248 the same as sunitinib?

SU011248 is also known as sunitinib, a small molecule tyrosine kinase inhibitor. In the clinical trial NCT00618124, SU011248 is administered in combination with capecitabine, another chemotherapy drug, to evaluate their combined use in treating solid tumors.