Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

December 20, 2018 updated by: Pfizer

AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

Study Overview

Status

Completed

Conditions

Kidney Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

723

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2605
    - The Canberra Hospital, Medical Oncology
- South Australia
  - Kurralta Park, South Australia, Australia, 5037
    - Ashford Cancer Centre Research
- Victoria
  - Ballarat, Victoria, Australia, 3350
    - Ballarat Oncology & Haematology Services
  - East Melbourne, Victoria, Australia, 3002
    - Peter MacCallum Cancer Centre
  - Heidelberg, Victoria, Australia, 3084
    - Austin Hospital, Austin Health
  - Heidelberg West, Victoria, Australia, 3081
    - Heidelberg Repatriation Hospital, Austin Health
Austria
- - Wien, Austria, 1020
    - Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien
  - Wien, Austria, A-1090
    - Universitaets-Klinik fuer Innere Medizin I
Brazil
- RJ
  - Rio de Janeiro, RJ, Brazil, 22260-020
    - Clinica Oncologistas Associados
- RS
  - Porto Alegre, RS, Brazil, 90050-170
    - Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
- SP
  - Barretos, SP, Brazil, 14784-400
    - Fundacao Pio Xii Hospital de Cancer de Barretos
  - Sao Paulo, SP, Brazil, 01509-900
    - Fundacao Antonio Prudente
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - British Columbia Cancer Agency - Cancer Centre for the Southern Interior
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Dr. Leon Richard Oncology Centre
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Dr. H. Bliss Murphy Cancer Centre
- Ontario
  - Oshawa, Ontario, Canada, L1G 2B9
    - RSM Durham Regional Cancer Centre Lakeridge Health Oshawa
China
- - Guangzhou, China, 510060
    - Sun Yet-sen University Cancer Center
  - Shanghai, China, 200127
    - Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
  - Tianjin, China, 300060
    - Tianjin Oncology Hospital,biology treatment department
- Chaoyang District
  - Beijing, Chaoyang District, China, 100021
    - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Jiangsu
  - Nanjing, Jiangsu, China, 210002
    - The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital
- P.R.
  - Beijing, P.R., China, 100036
    - Beijing Cancer Hospital
- Shaanxi
  - Xi'an, Shaanxi, China, 710054
    - Xijing Hospital, The Fourth Military Medical University
France
- - Bordeaux Cedex, France, 33075
    - Hôpital Saint-André
  - CRETEIL Cedex, France, 94010
    - Hopital Henri Mondor
  - Marseille Cedex 09, France, 13273
    - Institut Paoli-Calmettes
  - Paris Cedex 15, France, 75908
    - Hôpital Europeén Georges Pompidou
  - Rennes, France, 35042
    - Centre Eugene Marquis
  - St Herblain Cedex, France, 44805
    - Centre Rene Gauducheau - Service Oncologie Medicale
  - Tours Cedex 1, France, 37044
    - CHRU de Tours - Hopital Bretonneau
  - Vandoeuvre les Nancy, France, 54511
    - Centre Alexis Vautrin
  - Villejuif Cedex, France, 94805
    - Institut Gustave Roussy / Service d'Immunotherapie
- Cedex 08
  - Lyon, Cedex 08, France, 69373
    - Centre Léon Bérard
Germany
- - Aachen, Germany, 52074
    - RWTH Aachen, Urologische Klinik
  - Berlin, Germany, 12200
    - Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
  - Essen, Germany, 45122
    - Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen
  - Hannover, Germany, 30449
    - Klinikum Region Hannover Krankenhaus Siloah
  - Mainz, Germany, 55131
    - Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik
  - Muenchen, Germany, 81377
    - Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
  - Oldenburg, Germany, 26133
    - Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie
Greece
- Attiki
  - Athens, Attiki, Greece, 115 28
    - Alexandra University Hospital / Oncology Dept.
- Macedonia
  - Thessaloniki, Macedonia, Greece, 540 07
    - "Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology
India
- Haryana
  - Gurgaon, Haryana, India, 122002
    - Fortis Memorial Research Institute
- Kerala
  - Kochi, Kerala, India, 682 026
    - Amrita Institute of Medical Sciences
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Dept. of Medical Oncology, Tata Memorial Hospital
- Punjab
  - Ludhiana, Punjab, India, 141 008
    - Christian Medical College & Hospital
- Rajasthan
  - Jaipur, Rajasthan, India, 302017
    - Bhagwan Mahaveer Cancer Hospital and Research Center
Ireland
- - Dublin 24, Ireland
    - Oncology Department
Italy
- - Arezzo, Italy, 52100
    - UOC Oncologia Medica, Ospedale San Donato
  - Aviano (PN), Italy, 33081
    - Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS
  - Aviano (PN), Italy, 33081
    - Dipartimento dei laboratori diagnositici e per le terapie cellulari
  - Brescia, Italy, 25123
    - Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica
  - Cremona, Italy, 26100
    - Struttura Complessa di Oncologia
  - Genova, Italy, 16132
    - UOC Oncologia Medica B, IRCCS AO Universitaria San Martino
  - Milano, Italy, 20133
    - Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
  - Napoli, Italy, 80131
    - Divisione di Oncologia, AORN Antonio Cardarelli
  - Napoli, Italy, 80131
    - Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
  - Padova, Italy, 35128
    - Unita' Operativa Oncologia Medica 2, Regione del Veneto
  - Pavia, Italy, 27100
    - IRCCS Policlinico San Matteo
  - Roma, Italy, 00144
    - Struttura Complessa di Oncologia Medica A
  - Roma, Italy, 00152
    - Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano
  - Rozzano (MI), Italy, 20089
    - UO di Oncologia ed Ematologia, Istituto Clinico Humanitas
Japan
- - Akita, Japan, 010-8543
    - Akita University Hospital
  - Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Fukuoka, Japan, 812-8582
    - Kyushu University Hospital
  - Kumamoto, Japan, 860-8556
    - Kumamoto University Hospital
  - Tokushima, Japan, 770-8503
    - Tokushima University
  - Yamagata, Japan, 990-9585
    - Yamagata University Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8638
    - Hokkaido University Hospital
  - Sapporo-shi, Hokkaido, Japan, 0608543
    - Sapporo Medical University School of Medicine
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8577
    - University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology
- Osaka
  - Osakasayama, Osaka, Japan, 589-8511
    - Kinki University Hospital
- Shizuoka
  - Hamamatsu-City, Shizuoka, Japan, 431-3192
    - Hamamatsu University School of Medicine
  - Sunto-gun, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
- Tokyo
  - Arakawa-ku, Tokyo, Japan, 116-8567
    - Tokyo Women's Medical University Medical Center East, Department of Urology
  - Chuo-Ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Itabashi-ku, Tokyo, Japan, 173-8610
    - Nihon University Itabashi Hospital
  - Shinjuku-ku, Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University Hospital
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital
- Yamaguchi
  - Ube-shi, Yamaguchi, Japan, 755-8505
    - Yamaguchi University Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 602-715
    - Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 120-752
    - Severance Hospital
  - Seoul, Korea, Republic of, 137-701
    - Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
    - National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer
Poland
- - Gdansk, Poland, 80-210
    - Wojewodzkie Centrum Onkologii
  - Poznan, Poland, 60 569
    - Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
  - Poznan, Poland, 61-545
    - Pracownia Tomografii Komputerowej
  - Warszawa, Poland, 00-909
    - Klinika Onkologii, Wojskowy Instytut Medyczny
  - Wroclaw, Poland, 50-556
    - Klinika Urologii i Onkologii Urologicznej
- Wielkopolska
  - Poznan, Wielkopolska, Poland, 61-485
    - Centrum Medyczne HCP
  - Poznan, Wielkopolska, Poland, 61-866
    - Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie
Russian Federation
- - Moscow, Russian Federation, 115478
    - Cancer Research Center named after N.N. Blokhin, Biotherapy Department
  - Moscow, Russian Federation, 115478
    - Cancer Research Center named after N.N.Blokhin, Chemotherapy Department
  - Moscow, Russian Federation, 117997
    - Russian Research Center of Roentgenology and Radiology
  - Moscow, Russian Federation, 123060
    - The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation
  - Moscow, Russian Federation, 125284
    - Moscow Research Institute of Oncology P.A. Herzen
  - St. Petersburg, Russian Federation, 198255
    - City Clinical Oncology Dispensary
- Kaluga Region
  - Obninsk, Kaluga Region, Russian Federation, 249036
    - Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Centre Singapore
Slovakia
- - Bratislava, Slovakia, 833 10
    - Narodny onkologicky ustav
  - Bratislava, Slovakia, 812 50
    - Onkologicky Ustav sv. Alzbety
  - Zilina, Slovakia, 012 07
    - Nemocnica s poliklinikou Zilina
Spain
- - Barcelona, Spain, 08035
    - Hospital Vall D¿Hebron
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Malaga, Spain, 29010
    - Hospital Clinico Universitario Virgen de La Victoria
  - Sevilla, Spain, 41009
    - Hospital Universitario Virgen Macarena
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- Barcelona
  - L'hospitalet de Llobregat, Barcelona, Spain, 08907
    - Institut Catala d'Oncologia l'Hospitalet
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Clinica Universitaria de Navarra
  - Pamplona, Navarra, Spain, 31008
    - Hospital de Navarra
Sweden
- - Linkoping, Sweden, 581 85
    - Universitetssjukhuset, Onkologiska kliniken
  - Umea, Sweden, 901 85
    - Norrlands Universitetssjukhus, Onkologkliniken
  - Vaxjo, Sweden, 351 85
    - Onkologkliniken
Taiwan
- - Kaohsiung Hsien, Taiwan, 833
    - Chang Gung Medical Foundation-Kaohsiung Branch
  - Taichung, Taiwan, 407
    - Taichung Veterans General Hospital, Department of Surgery
  - Taipei, Taiwan, 100
    - Department of Oncology, National Taiwan University Hospital
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation-Linkou Branch
United Kingdom
- - Bebington, Wirral, United Kingdom, CH63 4JY
    - Clatterbridge Centre for Oncology NHS Foundation Trust
  - Birmingham, United Kingdom, B15 2TT
    - University of Birmingham, CRUK Institute for Cancer Studies
  - Bournemouth, United Kingdom, SO41 3QS
    - Royal Bournemouth & Poole Hospitals
  - Bristol, United Kingdom, BS2 8ED
    - Bristol Haematology and Oncology Centre
  - Cambridge, United Kingdom, CB2 0QQ
    - Addenbrooke's Hospital
  - Glasgow, United Kingdom, G12 0YH
    - The Beatson West of Scotland Cancer Centre
  - London, United Kingdom, EC1A 7BE
    - Department of Medical Oncology, St. Bartholomew's Hospital
  - Oxford, United Kingdom, OX3 7LJ
    - University Department of Medical Oncology/Oxford Cancer Centre
  - Surrey, United Kingdom, SM2 5PT
    - Royal Marsden Hospital NHS Foundation Trust
- England
  - London, England, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - Mount Vernon Cancer Centre
United States
- California
  - Burbank, California, United States, 91505
    - East Valley Hematology and Oncology medical Group
  - Burbank, California, United States, 91505
    - Maurice Berkowtiz, MD
  - Downey, California, United States, 90241
    - Agajanian Institute of Oncology and Hematology
  - Glendale, California, United States, 91206
    - Los Angeles Hematology/Oncology Medical Group
  - Los Angeles, California, United States, 90057
    - Kenmar Research Institute
  - Los Angeles, California, United States, 90095
    - UCLA
  - Los Angeles, California, United States, 90017
    - Los Angeles Hematology/Oncology Medical Group
  - Los Angeles, California, United States, 90033
    - LAC-USC Medical Center
  - Los Angeles, California, United States, 90095
    - Ronald Regan UCLA Medical Center
  - Los Angeles, California, United States, 90057
    - Metropolitan Hematology/Oncology Medical Group
  - Los Angeles, California, United States, 90033
    - USC Norris Cancer Hospital and Clinics
  - Montebello, California, United States, 90640
    - Agajanian Institute of Oncology and Hematology
  - West Covina, California, United States, 91790
    - Brian LeBerthon, MD, A Medical Corporation
  - Whittier, California, United States, 90606
    - Agajanian Institute of Oncology and Hematology
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers
  - Aurora, Colorado, United States, 80045
    - University of Colorado Denver: Division of Medical Oncology
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers
  - Colorado Springs, Colorado, United States, 80909
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers, LLP
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Medical Center
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Hospital, Lombardi Cancer Center
- Florida
  - Bonita Springs, Florida, United States, 34135
    - Florida Cancer Specialists
  - Bradenton, Florida, United States, 34209
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33914
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33990
    - Florida Cancer Specialists
  - Deerfield Beach, Florida, United States, 33442
    - University of Miami Sylvester at Deerfield Beach
  - Englewood, Florida, United States, 34223
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33901
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33916
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33905
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33908
    - Florida Cancer Specialists
  - Miami, Florida, United States, 33136
    - University of Miami Hospital and Clinics
  - Naples, Florida, United States, 34102
    - Florida Cancer Specialists
  - Naples, Florida, United States, 34119
    - Florida Cancer Specialists
  - Orlando, Florida, United States, 32806
    - Orlando Regional Medical Center
  - Orlando, Florida, United States, 32806
    - M.D. Anderson Cancer Center Orlando
  - Port Charlotte, Florida, United States, 33980
    - Florida Cancer Specialists
  - Sarasota, Florida, United States, 34232
    - Florida Cancer Specialists
  - Sarasota, Florida, United States, 34236
    - Florida Cancer Specialists
  - Venice, Florida, United States, 34285
    - Florida Cancer Specialists
  - Venice, Florida, United States, 34292
    - Florida Cancer Specialists
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Peachtree Hematology-Oncology Consultants, P.C.
  - Ringgold, Georgia, United States, 30736
    - Chattanooga Oncology and Hematology Associates, PC
- Idaho
  - Boise, Idaho, United States, 83712
    - Mountain States Tumor Institute
  - Fruitland, Idaho, United States, 83619
    - Mountain States Tumor Institute
  - Meridian, Idaho, United States, 83642
    - Mountain States Tumor Institute
  - Nampa, Idaho, United States, 83686
    - Mountain States Tumor Institute
  - Twin Falls, Idaho, United States, 83301
    - Mountain States Tumor Institute
- Illinois
  - Maywood, Illinois, United States, 60153
    - Loyola University Chicago Cardinal Bernardin Cancer Center
- Indiana
  - Carmel, Indiana, United States, 46032
    - Cental Indiana Cancer Centers
  - Fishers, Indiana, United States, 46037
    - Central Indiana Cancer Centers
  - Greenfield, Indiana, United States, 46140
    - Cental Indiana Cancer Centers
  - Indianapolis, Indiana, United States, 46227
    - Central Indiana Cancer Centers
  - Indianapolis, Indiana, United States, 46219
    - Central Indiana Cancer Centers
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5948
    - University of Michigan Health System
  - Detroit, Michigan, United States, 48201
    - Karmanos Cancer Institute
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Medical Center Fairview
- Missouri
  - Columbia, Missouri, United States, 65201
    - Missouri Cancer Associates
  - Saint Louis, Missouri, United States, 63141
    - St. John's Mercy Medical Center
  - Saint Louis, Missouri, United States, 63141
    - St. John's Mercy, David C. Pratt Cancer Center
  - Washington, Missouri, United States, 63090
    - St. John's Mercy Medical Center
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89135
    - Nevada Cancer Institute
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - The Cancer Center at Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - The Cancer Center at Hackensack University Medical Center - The Hillcrest Building
- New York
  - Bronx, New York, United States, 10466
    - Montefiore Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center
  - Oneida, New York, United States, 13421
    - Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.
  - Oswego, New York, United States, 13126
    - Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.
  - Syracuse, New York, United States, 13210-2306
    - SUNY Upstate Medical University
  - Syracuse, New York, United States, 13210
    - Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc
- North Carolina
  - Cary, North Carolina, United States, 27518
    - Raleigh Hematology Oncology Associates, DBA
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27710
    - Investigational Chemotherapy Services
  - Elizabeth City, North Carolina, United States, 27909
    - Virginia Oncology Associates
  - Elizabeth City, North Carolina, United States, 27909
    - Albermarie Hospitals
  - Raleigh, North Carolina, United States, 27607
    - Raleigh Hematology Oncology Associates, P.C.
- Ohio
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Columbus, Ohio, United States, 43210
    - Ohio State University
  - Columbus, Ohio, United States, 43210
    - Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
  - Columbus, Ohio, United States, 43211
    - James Care in Kenny
  - Mayfield Heights, Ohio, United States, 44124
    - Monarch
  - Mentor, Ohio, United States, 44060
    - Lake University - Ireland Cancer Center (LUICC)
  - Orange Village, Ohio, United States, 44122
    - UHHS - Chagrin Highlands
  - Westlake, Ohio, United States, 44145
    - UHHS - Westlake
- Oregon
  - Eugene, Oregon, United States, 97401-8122
    - Oncology Associates of Oregon, P.C.
  - Springfield, Oregon, United States, 97477
    - Willamette Valley Cancer Institute and Research Center
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19111-2497
    - Fox Chase Cancer Center
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas
  - Greenville, South Carolina, United States, 29615
    - Hematology and Oncology Associates of SC, LLC - Eastside Medical Center
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas, Seneca
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Chattanooga Oncology and Hematology Associates, PC
  - Chattanooga, Tennessee, United States, 37404
    - Chattanooga Oncology Hematology Associates P.C.
  - Franklin, Tennessee, United States, 37067
    - Tennessee Oncology, PLLC
  - Franklin, Tennessee, United States, 37067
    - Vanderbilt-Ingram Cancer Center-Cool Springs
  - Gallatin, Tennessee, United States, 37066
    - Tennessee Oncology, PLLC
  - Hermitage, Tennessee, United States, 37076
    - Tennessee Oncology, PLLC
  - Hixson, Tennessee, United States, 37343
    - Chattanooga Oncology & Hematology Associates
  - Lebanon, Tennessee, United States, 37087
    - Tennessee Oncology, PLLC
  - Murfreesboro, Tennessee, United States, 37130
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center
  - Nashville, Tennessee, United States, 37203
    - Sarah Cannon Research Institute
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37205
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37207
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37211
    - Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37232-6307
    - Vanderbilt-Ingram Cancer Center
  - Smyrna, Tennessee, United States, 37167
    - Tennessee Oncology, PLLC
- Texas
  - Austin, Texas, United States, 78745
    - Texas Oncology - South Austin
  - Austin, Texas, United States, 78705
    - Texas Oncology - Austin Midtown
  - Austin, Texas, United States, 78731
    - Texas Oncology - Austin Central
  - Austin, Texas, United States, 78705
    - Texas Oncology - Central Midtown
  - Austin, Texas, United States, 78758
    - Texas Oncolgoy - Austin North
  - Austin, Texas, United States, 78759
    - Texas Oncology - Austin Northwest
  - Bedford, Texas, United States, 76022
    - Texas Oncology, P.A.
  - Cedar Park, Texas, United States, 78613
    - Texas Oncology - Cedar Park
  - Dallas, Texas, United States, 75246
    - Texas Oncology - Baylor Charles A. Sammons Cancer Center
  - Fort Worth, Texas, United States, 76177
    - Investigational Products Center (IPC)
  - Fort Worth, Texas, United States, 76177
    - US Oncology Research and Clinical Pharmacy
  - Fort Worth, Texas, United States, 76177
    - Investigation Products Center (IPC)
  - Houston, Texas, United States, 77030
    - The University of Texas MD Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - Genitourinary Cancer Center
  - Round Rock, Texas, United States, 78681
    - Texas Oncology - Round Rock
  - Round Rock, Texas, United States, 78655
    - Texas Oncology - Seton Williamson
  - Tyler, Texas, United States, 75702
    - Texas Oncology, P.A.
  - Webster, Texas, United States, 77598
    - Texas Oncology - Clear Lake
  - Webster, Texas, United States, 77598-4420
    - Deke Slayton Cancer Center
- Virginia
  - Arlington, Virginia, United States, 22205
    - Virginia Cancer Specialists, PC
  - Chesapeake, Virginia, United States, 23320
    - Virginia Oncology Associates
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists, PC
  - Gainesville, Virginia, United States, 20155
    - Virginia Cancer Specialists, PC
  - Hampton, Virginia, United States, 23666
    - Virginia Oncology Associates
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists, PC
  - Newport News, Virginia, United States, 23606
    - Virginia Oncology Associates
  - Norfolk, Virginia, United States, 23502
    - Virginia Oncology Associates
  - Virginia Beach, Virginia, United States, 23456
    - Virginia Oncology Associates
  - Woodbridge, Virginia, United States, 22191
    - Virginia Cancer Specialists, PC
- Washington
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98109-1023
    - Seattle Cancer Care Alliance
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center, Section of Hematology/Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
Evidence of measurable disease
Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sorafenib	Drug: Sorafenib sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
Experimental: Axitinib	Drug: Axitinib (AG-013736) axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.	From initiation of treatment up to follow-up period (up to 3 years)
Objective Response Rate (ORR) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)
Duration of Response (DR) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.	From initiation of treatment up to follow-up period (up to 3 years)
Percentage of Participants With Adverse Events (AEs) by Severity Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.	From initiation of treatment up to follow-up period (up to 3 years)
Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs.	From initiation of treatment up to follow-up period (up to 3 years)
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis Time Frame: From initiation of treatment up to follow-up period (up to 3 years)	Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score Time Frame: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)	FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score Time Frame: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)	FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score Time Frame: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS) Time Frame: Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2008

Primary Completion (Actual)

August 31, 2010

Study Completion (Actual)

February 25, 2016

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 15, 2008

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Additional Relevant MeSH Terms

Other Study ID Numbers

A4061032
AXIS (Alias Study Number)
AXIS TRIAL
2008-001451-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer