Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
NCT ID: NCT00835978
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
213 participants
INTERVENTIONAL
2009-08-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
Study Groups
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A
Randomized arm
axitinib
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
B
Randomized arm
axitinib
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
C
Non-randomized arm
axitinib
axitinib 5mg BID (open-label)
Interventions
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axitinib
axitinib 5mg BID (open-label) + axitinib dose titration (blinded)
axitinib
axitinib 5mg BID (open-label) + placebo dose titration (blinded)
axitinib
axitinib 5mg BID (open-label)
Eligibility Criteria
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Inclusion Criteria
* no prior systemic therapy (including no prior adjuvant or neoadjuvant)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Blood Pressure \< or = 140/90mmHg
Exclusion Criteria
* using more than 2 blood pressure medications
18 Years
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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East Bay Medical Oncology/Hematology Medical Associates Inc.
Antioch, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
Diablo Valley Oncology and Hematology Medical Group Inc
Pleasant Hill, California, United States
East Bay Medical Oncology/Hematology Medical Associates Inc
Pleasant Hill, California, United States
East Bay Medical Oncology/Hematology Medical Associates Inc
San Leandro, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Investigational Drug Services, IUHSCC
Indianapolis, Indiana, United States
IU Health University Hospital
Indianapolis, Indiana, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
The University Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University, James Cancer Hospital
Columbus, Ohio, United States
JamesCare in Kenny
Columbus, Ohio, United States
West Chester Hospital Medical Building
West Chester, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Texas Oncology, Sammons Cancer Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Masarykuv onkologicky ustav
Brno, CZE, Czechia
Fakultni nemocnice Olomouc Onkologicka klinika
Olomouc, , Czechia
Fakultni nemocnice Na Bulovce
Prague, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice V Usti nad Labem, o.z.
Ústí nad Labem, , Czechia
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Klinikum der J. W. Goethe-Universitaet, Medizinische Klinik II
Frankfurt, , Germany
Medizinische Hochschule Hannover, Abt. Haematologie, Haemostaseologie & Onkologie
Hanover, , Germany
Eberhardt-Karls-Universitaet Tuebingen, Klinik fuer Urologie
Tübingen, , Germany
Klinikum Weiden Klinik fuer Urologie, Andrologie und Kinderurologie
Weiden, , Germany
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, Japan
National Cancer Center
Chuo-ku, Tokyo, Japan
Japanese Foundation For Cancer Research Cancer Institute Hospital
Koto-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Akita University Hospital
Akita, , Japan
Chiba Cancer Center
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Tokushima University Hospital
Tokushima, , Japan
Yamagata University Hospital
Yamagata, , Japan
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Obninsk, Kaluga Oblast, Russia
State Healthcare Institution "Leningrad Regional Oncology Dispensary"
Poselok Kuzmolovskiy, Vsevolozhskiy Region, Leningradskaya Oblast, Russia
FSBSI "N.N. Blokhin Russian Cancer Research Center"
Moscow, , Russia
FSBI"Russian Scientific Center of Roengenoradiology" of the MH of RF
Moscow, , Russia
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
Saint Petersburg, , Russia
Saint-Petersburg's State Healthcare Institution 'City Clinical Oncology Dispensary'
Saint Petersburg, , Russia
GBUZ "Samara Regional Clinical Oncology Dispensary"
Samara, , Russia
Hospital de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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References
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Tomita Y, Uemura H, Oya M, Shinohara N, Habuchi T, Fujii Y, Kamei Y, Umeyama Y, Bair AH, Rini BI. Patients with metastatic renal cell carcinoma who benefit from axitinib dose titration: analysis from a randomised, double-blind phase II study. BMC Cancer. 2019 Jan 7;19(1):17. doi: 10.1186/s12885-018-5224-6.
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.
Rini BI, Melichar B, Ueda T, Grunwald V, Fishman MN, Arranz JA, Bair AH, Pithavala YK, Andrews GI, Pavlov D, Kim S, Jonasch E. Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial. Lancet Oncol. 2013 Nov;14(12):1233-42. doi: 10.1016/S1470-2045(13)70464-9. Epub 2013 Oct 18.
Related Links
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Other Identifiers
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2008-007786-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4061046
Identifier Type: -
Identifier Source: org_study_id
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