Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
NCT ID: NCT00338884
Last Updated: 2012-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2006-09-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SUNITINIB MALATE.
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Interventions
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Sunitinib malate
Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Córdoba, Córdoba Province, Argentina
Pfizer Investigational Site
Rosario, Santa Fe Province, Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
East Bentleigh, Victoria, Australia
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Tainan City, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
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.
Barrios CH, Hernandez-Barajas D, Brown MP, Lee SH, Fein L, Liu JH, Hariharan S, Martell BA, Yuan J, Bello A, Wang Z, Mundayat R, Rha SY. Phase II trial of continuous once-daily dosing of sunitinib as first-line treatment in patients with metastatic renal cell carcinoma. Cancer. 2012 Mar 1;118(5):1252-9. doi: 10.1002/cncr.26440. Epub 2011 Sep 6.
Related Links
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Other Identifiers
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A6181110
Identifier Type: -
Identifier Source: org_study_id
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