AzTrials
AzTrials

Kidney NeoplasmsPhase 3NCT00678392

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

A Phase 3 study testing Axitinib (AG-013736) and Sorafenib in people with Kidney Neoplasms, run by Pfizer at 294 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Neoplasms
What is being tested?
Axitinib (AG-013736) and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
723 participants
Where
294 sitesin 22 countries
Study dates
3 Sep 2008to 25 Feb 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

294 sites in 22 countries.

294 sites in 22 countries

United States161 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5948

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205

  • Peachtree Hematology-Oncology Consultants, P.C.

    Atlanta, Georgia, 30318

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Colorado Denver: Division of Medical Oncology

    Aurora, Colorado, 80045

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - Central Midtown

    Austin, Texas, 78705

  • Texas Oncology - Austin Central

    Austin, Texas, 78731

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • Texas Oncolgoy - Austin North

    Austin, Texas, 78758

  • Texas Oncology - Austin Northwest

    Austin, Texas, 78759

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • East Valley Hematology and Oncology Medical Group

    Burbank, California, 91505

  • Maurice Berkowtiz, MD

    Burbank, California, 91505

  • Florida Cancer Specialists

    Cape Coral, Florida, 33914

  • Florida Cancer Specialists

    Cape Coral, Florida, 33990

  • Cental Indiana Cancer Centers

    Carmel, Indiana, 46032

  • Raleigh Hematology Oncology Associates, DBA

    Cary, North Carolina, 27518

  • Texas Oncology - Cedar Park

    Cedar Park, Texas, 78613

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga Oncology and Hematology Associates, PC

    Chattanooga, Tennessee, 37404

  • Chattanooga Oncology Hematology Associates P.C.

    Chattanooga, Tennessee, 37404

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80909

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

    Columbus, Ohio, 43210

  • Ohio State University

    Columbus, Ohio, 43210

  • James Care in Kenny

    Columbus, Ohio, 43211

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Miami Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Agajanian Institute of Oncology and Hematology

    Downey, California, 90241

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Investigational Chemotherapy Services

    Durham, North Carolina, 27710

  • Cancer Centers of the Carolinas

    Easley, South Carolina, 29605

  • Albermarie Hospitals

    Elizabeth City, North Carolina, 27909

  • Virginia Oncology Associates

    Elizabeth City, North Carolina, 27909

  • Florida Cancer Specialists

    Englewood, Florida, 34223

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401-8122

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Central Indiana Cancer Centers

    Fishers, Indiana, 46037

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Investigation Products Center (IPC)

    Fort Worth, Texas, 76177

  • Investigational Products Center (IPC)

    Fort Worth, Texas, 76177

  • US Oncology Research and Clinical Pharmacy

    Fort Worth, Texas, 76177

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Vanderbilt-Ingram Cancer Center-Cool Springs

    Franklin, Tennessee, 37067

  • Mountain States Tumor Institute

    Fruitland, Idaho, 83619

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Los Angeles Hematology/Oncology Medical Group

    Glendale, California, 91206

  • Cental Indiana Cancer Centers

    Greenfield, Indiana, 46140

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Hematology and Oncology Associates of SC, LLC - Eastside Medical Center

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Cancer Center at Hackensack University Medical Center - The Hillcrest Building

    Hackensack, New Jersey, 07601

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Chattanooga Oncology & Hematology Associates

    Hixson, Tennessee, 37343

  • Genitourinary Cancer Center

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Los Angeles Hematology/Oncology Medical Group

    Los Angeles, California, 90017

  • LAC-USC Medical Center

    Los Angeles, California, 90033

  • USC Norris Cancer Hospital and Clinics

    Los Angeles, California, 90033

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Metropolitan Hematology/Oncology Medical Group

    Los Angeles, California, 90057

  • Ronald Regan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA

    Los Angeles, California, 90095

  • Monarch

    Mayfield Heights, Ohio, 44124

  • Loyola University Chicago Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60153

  • Lake University - Ireland Cancer Center (LUICC)

    Mentor, Ohio, 44060

  • Mountain States Tumor Institute

    Meridian, Idaho, 83642

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55455

  • Agajanian Institute of Oncology and Hematology

    Montebello, California, 90640

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37130

  • Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Florida Cancer Specialists

    Naples, Florida, 34119

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6307

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.

    Oneida, New York, 13421

  • UHHS - Chagrin Highlands

    Orange, Ohio, 44122

  • M.D. Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.

    Oswego, New York, 13126

  • Rocky Mountain Cancer Centers

    Parker, Colorado, 80138

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Raleigh Hematology Oncology Associates, P.C.

    Raleigh, North Carolina, 27607

  • Chattanooga Oncology and Hematology Associates, PC

    Ringgold, Georgia, 30736

  • Texas Oncology - Seton Williamson

    Round Rock, Texas, 78655

  • Texas Oncology - Round Rock

    Round Rock, Texas, 78681

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Virginia Mason Medical Center, Section of Hematology/Oncology

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Cancer Centers of the Carolinas, Seneca

    Seneca, South Carolina, 29672

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Cancer Centers of the Carolinas

    Spartanburg, South Carolina, 29307

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • St. John's Mercy, David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Suny Upstate Medical University

    Syracuse, New York, 13210-2306

  • Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10466

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Mountain States Tumor Institute

    Twin Falls, Idaho, 83301

  • Texas Oncology, P.A.

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    Venice, Florida, 34285

  • Florida Cancer Specialists

    Venice, Florida, 34292

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • St. John's Mercy Medical Center

    Washington, Missouri, 63090

  • Georgetown University Hospital, Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Deke Slayton Cancer Center

    Webster, Texas, 77598-4420

  • Texas Oncology - Clear Lake

    Webster, Texas, 77598

  • Brian LeBerthon, MD, A Medical Corporation

    West Covina, California, 91790

  • UHHS - Westlake

    Westlake, Ohio, 44145

  • Agajanian Institute of Oncology and Hematology

    Whittier, California, 90606

  • Virginia Cancer Specialists, PC

    Woodbridge, Virginia, 22191

Other trials in United States

Japan18 sites

  • Akita University Hospital

    Akita, 010-8543

  • Tokyo Women's Medical University Medical Center East, Department of Urology

    Arakawa-ku, Tokyo, 116-8567

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka, 431-3192

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8638

  • Sapporo Medical University School of Medicine

    Sapporo, Hokkaido, 0608543

  • Kinki University Hospital

    Sayama, Osaka, 589-8511

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Tokushima University

    Tokushima, 770-8503

  • University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology

    Tsukuba, Ibaraki, 305-8577

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505

  • Yamagata University Hospital

    Yamagata, 990-9585

Other trials in Japan

Italy14 sites

  • UOC Oncologia Medica, Ospedale San Donato

    Arezzo, 52100

  • Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS

    Aviano (PN), 33081

  • Dipartimento dei laboratori diagnositici e per le terapie cellulari

    Aviano (PN), 33081

  • Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica

    Brescia, 25123

  • Struttura Complessa di Oncologia

    Cremona, 26100

  • UOC Oncologia Medica B, IRCCS AO Universitaria San Martino

    Genova, 16132

  • Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

    Milan, 20133

  • Divisione di Oncologia, AORN Antonio Cardarelli

    Naples, 80131

  • Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

    Naples, 80131

  • Unita' Operativa Oncologia Medica 2, Regione del Veneto

    Padova, 35128

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Struttura Complessa di Oncologia Medica A

    Roma, 00144

  • Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano

    Roma, 00152

  • UO di Oncologia ed Ematologia, Istituto Clinico Humanitas

    Rozzano (MI), 20089

Other trials in Italy

United Kingdom11 sites

  • Clatterbridge Centre for Oncology NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • University of Birmingham, CRUK Institute for Cancer Studies

    Birmingham, B15 2TT

  • Royal Bournemouth & Poole Hospitals

    Bournemouth, SO41 3QS

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YH

  • Royal Marsden Hospital

    London, England, SW3 6JJ

  • Department of Medical Oncology, St. Bartholomew's Hospital

    London, EC1A 7BE

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

  • University Department of Medical Oncology/Oxford Cancer Centre

    Oxford, OX3 7LJ

  • Royal Marsden Hospital NHS Foundation Trust

    Surrey, SM2 5PT

Other trials in United Kingdom

France10 sites

  • Hopital Saint-André

    Bordeaux, 33075

  • Hôpital Henri Mondor

    Créteil, 94010

  • Centre Leon Berard

    Lyon, Cedex 08, 69373

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Gauducheau - Service Oncologie Medicale

    Saint-Herblain, 44805

  • CHRU de Tours - Hopital Bretonneau

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy / Service d'Immunotherapie

    Villejuif, 94805

Other trials in France

Spain9 sites

  • Hospital Vall D¿Hebron

    Barcelona, 08035

  • Institut Catala D'Oncologia L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de La Victoria

    Málaga, 29010

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

China7 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Chaoyang District, 100021

  • Beijing Cancer Hospital

    Beijing, P.R., 100036

  • Sun Yet-Sen University Cancer Center

    Guangzhou, 510060

  • The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital

    Nanjing, Jiangsu, 210002

  • Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

  • Tianjin Oncology Hospital,biology treatment department

    Tianjin, 300060

  • Xijing Hospital, The Fourth Military Medical University

    Xi'an, Shaanxi, 710054

Other trials in China

Germany7 sites

  • RWTH Aachen, Urologische Klinik

    Aachen, 52074

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12200

  • Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen

    Essen, 45122

  • Klinikum Region Hannover Krankenhaus Siloah

    Hanover, 30449

  • Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik

    Mainz, 55131

  • Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

    München, 81377

  • Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie

    Oldenburg, 26133

Other trials in Germany

Poland7 sites

  • Wojewodzkie Centrum Onkologii

    Gdansk, 80-210

  • Centrum Medyczne HCP

    Poznan, Wielkopolska, 61-485

  • Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie

    Poznan, Wielkopolska, 61-866

  • Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

    Poznan, 60 569

  • Pracownia Tomografii Komputerowej

    Poznan, 61-545

  • Klinika Onkologii, Wojskowy Instytut Medyczny

    Warsaw, 00-909

  • Klinika Urologii i Onkologii Urologicznej

    Wroclaw, 50-556

Other trials in Poland

Russia7 sites

  • Cancer Research Center named after N.N. Blokhin, Biotherapy Department

    Moscow, 115478

  • Cancer Research Center named after N.N.Blokhin, Chemotherapy Department

    Moscow, 115478

  • Russian Research Center of Roentgenology and Radiology

    Moscow, 117997

  • The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation

    Moscow, 123060

  • Moscow Research Institute of Oncology P.A. Herzen

    Moscow, 125284

  • Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

    Obninsk, Kaluga Oblast, 249036

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

Other trials in Russia

Australia6 sites

  • Ballarat Oncology & Haematology Services

    Ballarat, Victoria, 3350

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • The Canberra Hospital, Medical Oncology

    Garran, Australian Capital Territory, 2605

  • Austin Hospital, Austin Health

    Heidelberg, Victoria, 3084

  • Heidelberg Repatriation Hospital, Austin Health

    Heidelberg West, Victoria, 3081

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

Other trials in Australia

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • British Columbia Cancer Agency - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Dr. Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • RSM Durham Regional Cancer Centre Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

South Korea6 sites

  • Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology

    Busan, 602-715

  • National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology

    Seoul, 137-701

Other trials in South Korea

India5 sites

  • Fortis Memorial Research Institute

    Gurgaon, Haryana, 122002

  • Bhagwan Mahaveer Cancer Hospital and Research Center

    Jaipur, Rajasthan, 302017

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682 026

  • Christian Medical College & Hospital

    Ludhiana, Punjab, 141 008

  • Dept. of Medical Oncology, Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

Other trials in India

Brazil4 sites

  • Fundacao Pio XII Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Clinica Oncologistas Associados

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Fundacao Antonio Prudente

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

Taiwan4 sites

  • Chang Gung Medical Foundation-Kaohsiung Branch

    Kaohsiung Hsien, 833

  • Taichung Veterans General Hospital, Department of Surgery

    Taichung, 407

  • Department of Oncology, National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Slovakia3 sites

  • Onkologicky Ustav sv. Alzbety

    Bratislava, 812 50

  • Narodny Onkologicky ustav

    Bratislava, 833 10

  • Nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

Sweden3 sites

  • Universitetssjukhuset, Onkologiska kliniken

    Linköping, 581 85

  • Norrlands Universitetssjukhus, Onkologkliniken

    Umeå, 901 85

  • Onkologkliniken

    Vaxjo, 351 85

Other trials in Sweden

Austria2 sites

  • Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien

    Vienna, 1020

  • Universitaets-Klinik fuer Innere Medizin I

    Vienna, A-1090

Other trials in Austria

Greece2 sites

  • Alexandra University Hospital / Oncology Dept.

    Athens, Attica, 115 28

  • "Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology

    Thessaloniki, Macedonia, 540 07

Other trials in Greece

Ireland1 site

  • Oncology Department

    Dublin

Other trials in Ireland

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: 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.

Being tested
Axitinib (AG-013736), Sorafenib
Keywords
Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axitinib (AG-013736)Drug

    axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing

  • SorafenibDrug

    sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing

Study groups in NCT00678392
Study groupRoleWhat they receive
AxitinibExperimentalNot described
Receives: Drug: Axitinib (AG-013736)
SorafenibActive comparatorNot described
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

Secondary outcomes (13)

  1. Overall Survival (OS)

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  2. Objective Response Rate (ORR)

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  3. Duration of Response (DR)

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  4. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  5. Percentage of Participants With Adverse Events (AEs) by Severity

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  6. Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  7. Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  8. Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  9. Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis

    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.

    Measured: From initiation of treatment up to follow-up period (up to 3 years)

  10. Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score

    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.

    Measured: 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)

  11. Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score

    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.

    Measured: 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)

  12. Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score

    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.

    Measured: 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)

  13. Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2008 (estimated)
  2. Study start3 Sep 2008
  3. Primary completion31 Aug 2010
  4. Study completion25 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
723 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00678392
Sponsor's protocol ID
A4061032
Other IDs
AXIS TRIAL, 2008-001451-21, AXIS, 2008
Status last verified
Dec 2018
First submitted
12 May 2008
Last updated
9 Jan 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37526095

  • Murphy 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.

    PubMed 32363929

  • Bracarda 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.

    PubMed 31072748

  • 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.

    PubMed 28410911

  • 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.

    PubMed 27238653

  • 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.

    PubMed 25577718

  • Escudier 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.

    PubMed 24823696

  • Ueda 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.

    PubMed 23630366

  • Motzer 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.

    PubMed 23598172

  • Cella 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.

    PubMed 23579211

  • Rini 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.

    PubMed 22056247

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Axitinib (AG-013736) and Sorafenib in people with Kidney Neoplasms, run by Pfizer at 294 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 294 sites in United States, Japan, Italy, United Kingdom, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From initiation of treatment up to follow-up period (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678392, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in