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SU-011, 248

Phase 2

Kidney Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 7, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

SU-011, 248 · 1 trial · 1 indication

Phase 2 1
NCT00054886Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney CancerKidney Neoplasms
COMPLETED63 Analytics
PHASE2COMPLETED
Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer
Kidney NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint was overall response rate (ORR) and the ORR achieved for the study was 40%.

Secondary Endpoints

The secondary endpoints included time to progression (TTP) and overall survival (OS). The median TTP for the study was 8.7 months and the median OS was 16.4 months. SU011248 was generally well tolerated.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
SU-011,248DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer. * The patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given. * Any side effects from prior therapy must have subsided, and blood and...

Countries:United States
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Frequently asked questions about SU-011, 248

What is SU-011,248 used for?

SU-011,248 is an investigational small molecule being studied for the treatment of kidney neoplasms, specifically advanced kidney cancer. It is being evaluated in adult patients with this condition. The drug is currently in Phase 2 clinical development and is not yet approved for any use.

Who makes SU-011,248?

SU-011,248 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced kidney cancer.

What phase is SU-011,248 in?

SU-011,248 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of kidney neoplasms, and its clinical trial program is ongoing to assess its safety and efficacy.

What clinical trials is SU-011,248 in?

SU-011,248 has been studied in a Phase 2 clinical trial identified as NCT00054886, titled 'Study of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer.' This trial, which enrolled 63 participants in the United States, has been completed. The study was uncontrolled and not randomized or double-blinded.

Is SU-011,248 FDA approved?

SU-011,248 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of kidney neoplasms. The drug has been studied in a completed clinical trial, but it has not received regulatory approval for any indication.