Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
4 other identifiers
interventional
723
21 countries
288
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
Longer than P75 for phase_3
288 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedStudy Start
First participant enrolled
September 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2010
CompletedResults Posted
Study results publicly available
March 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2016
CompletedJanuary 9, 2019
December 1, 2018
2 years
May 12, 2008
February 25, 2012
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
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 Outcomes (13)
Overall Survival (OS)
From initiation of treatment up to follow-up period (up to 3 years)
Objective Response Rate (ORR)
From initiation of treatment up to follow-up period (up to 3 years)
Duration of Response (DR)
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)
From initiation of treatment up to follow-up period (up to 3 years)
Percentage of Participants With Adverse Events (AEs) by Severity
From initiation of treatment up to follow-up period (up to 3 years)
- +8 more secondary outcomes
Study Arms (2)
Axitinib
EXPERIMENTALSorafenib
ACTIVE COMPARATORInterventions
axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing
sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (294)
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505, United States
Maurice Berkowtiz, MD
Burbank, California, 91505, United States
Agajanian Institute of Oncology and Hematology
Downey, California, 90241, United States
Los Angeles Hematology/Oncology Medical Group
Glendale, California, 91206, United States
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, 90017, United States
LAC-USC Medical Center
Los Angeles, California, 90033, United States
USC Norris Cancer Hospital and Clinics
Los Angeles, California, 90033, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
Metropolitan Hematology/Oncology Medical Group
Los Angeles, California, 90057, United States
Ronald Regan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA
Los Angeles, California, 90095, United States
Agajanian Institute of Oncology and Hematology
Montebello, California, 90640, United States
Brian LeBerthon, MD, A Medical Corporation
West Covina, California, 91790, United States
Agajanian Institute of Oncology and Hematology
Whittier, California, 90606, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
University of Colorado Denver: Division of Medical Oncology
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Georgetown University Hospital, Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34209, United States
Florida Cancer Specialists
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists
Cape Coral, Florida, 33990, United States
University of Miami Sylvester at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists
Englewood, Florida, 34223, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Naples, Florida, 34119, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, 30318, United States
Chattanooga Oncology and Hematology Associates, PC
Ringgold, Georgia, 30736, United States
Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Mountain States Tumor Institute
Fruitland, Idaho, 83619, United States
Mountain States Tumor Institute
Meridian, Idaho, 83642, United States
Mountain States Tumor Institute
Nampa, Idaho, 83686, United States
Mountain States Tumor Institute
Twin Falls, Idaho, 83301, United States
Loyola University Chicago Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
Cental Indiana Cancer Centers
Carmel, Indiana, 46032, United States
Central Indiana Cancer Centers
Fishers, Indiana, 46037, United States
Cental Indiana Cancer Centers
Greenfield, Indiana, 46140, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5948, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
St. John's Mercy, David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
St. John's Mercy Medical Center
Washington, Missouri, 63090, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Cancer Center at Hackensack University Medical Center - The Hillcrest Building
Hackensack, New Jersey, 07601, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.
Oneida, New York, 13421, United States
Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.
Oswego, New York, 13126, United States
Suny Upstate Medical University
Syracuse, New York, 13210-2306, United States
Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10466, United States
Raleigh Hematology Oncology Associates, DBA
Cary, North Carolina, 27518, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Services
Durham, North Carolina, 27710, United States
Albermarie Hospitals
Elizabeth City, North Carolina, 27909, United States
Virginia Oncology Associates
Elizabeth City, North Carolina, 27909, United States
Raleigh Hematology Oncology Associates, P.C.
Raleigh, North Carolina, 27607, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 43210, United States
James Care in Kenny
Columbus, Ohio, 43211, United States
Monarch
Mayfield Heights, Ohio, 44124, United States
Lake University - Ireland Cancer Center (LUICC)
Mentor, Ohio, 44060, United States
UHHS - Chagrin Highlands
Orange, Ohio, 44122, United States
UHHS - Westlake
Westlake, Ohio, 44145, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401-8122, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cancer Centers of the Carolinas
Easley, South Carolina, 29605, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Hematology and Oncology Associates of SC, LLC - Eastside Medical Center
Greenville, South Carolina, 29615, United States
Cancer Centers of the Carolinas, Seneca
Seneca, South Carolina, 29672, United States
Cancer Centers of the Carolinas
Spartanburg, South Carolina, 29307, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Chattanooga Oncology Hematology Associates P.C.
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Vanderbilt-Ingram Cancer Center-Cool Springs
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Chattanooga Oncology & Hematology Associates
Hixson, Tennessee, 37343, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
Texas Oncology - Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology - Central Midtown
Austin, Texas, 78705, United States
Texas Oncology - Austin Central
Austin, Texas, 78731, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
Texas Oncolgoy - Austin North
Austin, Texas, 78758, United States
Texas Oncology - Austin Northwest
Austin, Texas, 78759, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Texas Oncology - Cedar Park
Cedar Park, Texas, 78613, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Investigation Products Center (IPC)
Fort Worth, Texas, 76177, United States
Investigational Products Center (IPC)
Fort Worth, Texas, 76177, United States
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, 76177, United States
Genitourinary Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Seton Williamson
Round Rock, Texas, 78655, United States
Texas Oncology - Round Rock
Round Rock, Texas, 78681, United States
Texas Oncology, P.A.
Tyler, Texas, 75702, United States
Deke Slayton Cancer Center
Webster, Texas, 77598-4420, United States
Texas Oncology - Clear Lake
Webster, Texas, 77598, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22205, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, 20155, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Cancer Specialists, PC
Leesburg, Virginia, 20176, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191, United States
Virginia Mason Medical Center, Section of Hematology/Oncology
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
The Canberra Hospital, Medical Oncology
Garran, Australian Capital Territory, 2605, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Ballarat Oncology & Haematology Services
Ballarat, Victoria, 3350, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Austin Hospital, Austin Health
Heidelberg, Victoria, 3084, Australia
Heidelberg Repatriation Hospital, Austin Health
Heidelberg West, Victoria, 3081, Australia
Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien
Vienna, 1020, Austria
Universitaets-Klinik fuer Innere Medizin I
Vienna, A-1090, Austria
Clinica Oncologistas Associados
Rio de Janeiro, Rio de Janeiro, 22260-020, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency - Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
RSM Durham Regional Cancer Centre Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Chaoyang District, 100021, China
The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
Beijing Cancer Hospital
Beijing, P.R., 100036, China
Xijing Hospital, The Fourth Military Medical University
Xi'an, Shaanxi, 710054, China
Sun Yet-Sen University Cancer Center
Guangzhou, 510060, China
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Tianjin Oncology Hospital,biology treatment department
Tianjin, 300060, China
Centre Leon Berard
Lyon, Cedex 08, 69373, France
Hopital Saint-André
Bordeaux, 33075, France
Hôpital Henri Mondor
Créteil, 94010, France
Institut Paoli-Calmettes
Marseille, 13273, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Rene Gauducheau - Service Oncologie Medicale
Saint-Herblain, 44805, France
CHRU de Tours - Hopital Bretonneau
Tours, 37044, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy / Service d'Immunotherapie
Villejuif, 94805, France
RWTH Aachen, Urologische Klinik
Aachen, 52074, Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12200, Germany
Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen
Essen, 45122, Germany
Klinikum Region Hannover Krankenhaus Siloah
Hanover, 30449, Germany
Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik
Mainz, 55131, Germany
Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
München, 81377, Germany
Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie
Oldenburg, 26133, Germany
Alexandra University Hospital / Oncology Dept.
Athens, Attica, 115 28, Greece
"Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology
Thessaloniki, Macedonia, 540 07, Greece
Fortis Memorial Research Institute
Gurgaon, Haryana, 122002, India
Amrita Institute of Medical Sciences
Kochi, Kerala, 682 026, India
Dept. of Medical Oncology, Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Christian Medical College & Hospital
Ludhiana, Punjab, 141 008, India
Bhagwan Mahaveer Cancer Hospital and Research Center
Jaipur, Rajasthan, 302017, India
Oncology Department
Dublin, Ireland
UOC Oncologia Medica, Ospedale San Donato
Arezzo, 52100, Italy
Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS
Aviano (PN), 33081, Italy
Dipartimento dei laboratori diagnositici e per le terapie cellulari
Aviano (PN), 33081, Italy
Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica
Brescia, 25123, Italy
Struttura Complessa di Oncologia
Cremona, 26100, Italy
UOC Oncologia Medica B, IRCCS AO Universitaria San Martino
Genova, 16132, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
Milan, 20133, Italy
Divisione di Oncologia, AORN Antonio Cardarelli
Napoli, 80131, Italy
Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
Napoli, 80131, Italy
Unita' Operativa Oncologia Medica 2, Regione del Veneto
Padua, 35128, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Struttura Complessa di Oncologia Medica A
Roma, 00144, Italy
Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano
Roma, 00152, Italy
UO di Oncologia ed Ematologia, Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8638, Japan
Sapporo Medical University School of Medicine
Sapporo, Hokkaido, 0608543, Japan
University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology
Tsukuba, Ibaraki, 305-8577, Japan
Kinki University Hospital
Sayama, Osaka, 589-8511, Japan
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Tokyo Women's Medical University Medical Center East, Department of Urology
Arakawa-ku, Tokyo, 116-8567, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, 755-8505, Japan
Akita University Hospital
Akita, 010-8543, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Tokushima University
Tokushima, 770-8503, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Centrum Medyczne HCP
Poznan, Wielkopolska, 61-485, Poland
Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie
Poznan, Wielkopolska, 61-866, Poland
Wojewodzkie Centrum Onkologii
Gdansk, 80-210, Poland
Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, 60 569, Poland
Pracownia Tomografii Komputerowej
Poznan, 61-545, Poland
Klinika Onkologii, Wojskowy Instytut Medyczny
Warsaw, 00-909, Poland
Klinika Urologii i Onkologii Urologicznej
Wroclaw, 50-556, Poland
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Obninsk, Kaluga Oblast, 249036, Russia
Cancer Research Center named after N.N. Blokhin, Biotherapy Department
Moscow, 115478, Russia
Cancer Research Center named after N.N.Blokhin, Chemotherapy Department
Moscow, 115478, Russia
Russian Research Center of Roentgenology and Radiology
Moscow, 117997, Russia
The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation
Moscow, 123060, Russia
Moscow Research Institute of Oncology P.A. Herzen
Moscow, 125284, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
National Cancer Centre Singapore
Singapore, 169610, Singapore
Onkologicky Ustav sv. Alzbety
Bratislava, 812 50, Slovakia
Narodny Onkologicky ustav
Bratislava, 833 10, Slovakia
Nemocnica s poliklinikou Zilina
Žilina, 012 07, Slovakia
National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer
Goyang-si, Gyeonggi-do, 410-769, South Korea
Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
Busan, 602-715, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology
Seoul, 137-701, South Korea
Institut Catala D'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Vall D¿Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Universitetssjukhuset, Onkologiska kliniken
Linköping, 581 85, Sweden
Norrlands Universitetssjukhus, Onkologkliniken
Umeå, 901 85, Sweden
Onkologkliniken
Vaxjo, 351 85, Sweden
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung Hsien, 833, Taiwan
Taichung Veterans General Hospital, Department of Surgery
Taichung, 407, Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, 100, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Royal Marsden Hospital
London, England, SW3 6JJ, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
Bebington, Wirral, CH63 4JY, United Kingdom
University of Birmingham, CRUK Institute for Cancer Studies
Birmingham, B15 2TT, United Kingdom
Royal Bournemouth & Poole Hospitals
Bournemouth, SO41 3QS, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YH, United Kingdom
Department of Medical Oncology, St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
University Department of Medical Oncology/Oxford Cancer Centre
Oxford, OX3 7LJ, United Kingdom
Royal Marsden Hospital NHS Foundation Trust
Surrey, SM2 5PT, United Kingdom
Related Publications (11)
Rini BI, Atkins MB, Choueiri TK, Teresi RE, Rosbrook B, Thakur M, Hutson TE. Plain language summary looking at how long side effects last after treatment with axitinib is stopped in people with advanced renal cell carcinoma. Future Oncol. 2023 Dec;19(40):2623-2629. doi: 10.2217/fon-2023-0233. Epub 2023 Aug 1.
PMID: 37526095DERIVEDMurphy DA, Rini BI, Escudier B, Motzer RJ, Wang P, Li S, Williams JA, Tarazi JC, Martini JF. Angiogenic and immunomodulatory biomarkers in axitinib-treated patients with advanced renal cell carcinoma. Future Oncol. 2020 Jun;16(17):1199-1210. doi: 10.2217/fon-2020-0212. Epub 2020 May 4.
PMID: 32363929DERIVEDBracarda S, Bamias A, Casper J, Negrier S, Sella A, Staehler M, Tarazi J, Felici A, Rosbrook B, Jardinaud-Lopez M, Escudier B. Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial. Clin Genitourin Cancer. 2019 Jun;17(3):e689-e703. doi: 10.1016/j.clgc.2019.03.017. Epub 2019 Apr 1.
PMID: 31072748DERIVEDde 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.
PMID: 28410911DERIVEDGrunwald 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.
PMID: 27238653DERIVEDGrunwald 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.
PMID: 25577718DERIVEDEscudier B, Michaelson MD, Motzer RJ, Hutson TE, Clark JI, Lim HY, Porfiri E, Zalewski P, Kannourakis G, Staehler M, Tarazi J, Rosbrook B, Cisar L, Hariharan S, Kim S, Rini BI. Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial. Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.
PMID: 24823696DERIVEDUeda T, Uemura H, Tomita Y, Tsukamoto T, Kanayama H, Shinohara N, Tarazi J, Chen C, Kim S, Ozono S, Naito S, Akaza H. Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol. 2013 Jun;43(6):616-28. doi: 10.1093/jjco/hyt054. Epub 2013 Apr 28.
PMID: 23630366DERIVEDMotzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16.
PMID: 23598172DERIVEDCella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer. 2013 Apr 30;108(8):1571-8. doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.
PMID: 23579211DERIVEDRini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4.
PMID: 22056247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 15, 2008
Study Start
September 3, 2008
Primary Completion
August 31, 2010
Study Completion
February 25, 2016
Last Updated
January 9, 2019
Results First Posted
March 27, 2012
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
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.