A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
NCT ID: NCT00077974
Last Updated: 2010-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2004-02-29
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
SU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Interventions
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SU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
* Prior nephrectomy
Exclusion Criteria
* History of or known brain metastases
* Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Duarte, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Countries
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References
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de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181006
Identifier Type: -
Identifier Source: org_study_id
NCT00082849
Identifier Type: -
Identifier Source: nct_alias