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SU011248

Phase 2

Urothelial Cancer | Small molecule | Oncology |Avalon GloboCare Corp.|Last Updated: Aug 22, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

SU011248 · 1 trial · 3 indications

Phase 2 1
NCT00578526SU011248 for Platinum-Refractory Urothelial Cancer Evaluation TrialUrothelial Cancer
COMPLETED64 Analytics
PHASE2COMPLETED
SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial
Urothelial CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival
4 months

Secondary Endpoints

objective response rate
Study Duration
duration of response
study duration
Change in health-related quality of life
Study Duration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATORSU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Arm 2PLACEBO_COMPARATOR1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.

Interventions

NameTypeDescription
SU011248DRUG50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
PlaceboDRUG50 mg capsule OD PO for 28 days then 14 days rest until disease progression
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract * Mixed histology with predominant TCC allowed. * Failed, intolerant or ineligible for cisplatin based chemo * Measurable Disease (RECIST)Not previously ...

Countries:Canada
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Frequently asked questions about SU011248

What is SU011248 used for?

SU011248 is an investigational small molecule being studied for the treatment of urothelial cancer, also referred to as bladder cancer, in adults. It is currently in Phase 2 clinical development and has been evaluated in a completed clinical trial for this indication.

Who makes SU011248?

SU011248 is being developed by Avalon GloboCare Corp., a biopharmaceutical company traded under the ticker symbol ALBT. The company is conducting clinical research on this investigational drug for the treatment of urothelial cancer.

What phase is SU011248 in?

SU011248 is in Phase 2 clinical development. It has completed one Phase 2 trial for urothelial cancer, and it remains an investigational drug that has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is SU011248 in?

SU011248 has been studied in one completed Phase 2 clinical trial, identified as NCT00578526, titled 'SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial.' This trial enrolled 64 participants with urothelial or bladder cancer in Canada and was placebo-controlled.

Is SU011248 the same as sunitinib?

SU011248 is the investigational code name for the drug also known as sunitinib. It is a small molecule being studied for its potential use in treating urothelial cancer, and it has been evaluated in a Phase 2 clinical trial for this condition.