Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Last updated: April 9, 2022
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Urothelial Tract Cancer

Urologic Cancer

Urothelial Cancer

Treatment

Sorafenib

Axitinib (AG-013736)

Clinical Study ID

NCT00920816
A4061051
2010-018585-23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented metastatic renal cell cancer with a component of clear cellhistology.
  • Evidence of measurable disease.
  • Patients with mRCC must have received no prior systemic first-line therapy or musthave progressive disease per RECIST (version 1.0) after one prior systemic first lineregimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 492
Treatment Group(s): 2
Primary Treatment: Sorafenib
Phase: 3
Study Start date:
August 25, 2009
Estimated Completion Date:
April 29, 2021

Connect with a study center

  • Clinic of Oncology

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Institute of Oncology, University Hospital Center Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy

    Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

  • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya

    Sofia, 1756
    Bulgaria

    Site Not Available

  • SBALOZ D-r Marko Markov-Varna

    Varna, 9000
    Bulgaria

    Site Not Available

  • Instituto Clinico Oncologico del Sur

    Temuco, Cautin 4810469
    Chile

    Site Not Available

  • Pfizer Investigational Site

    Providencia, Santiago, RM 7501088
    Chile

    Site Not Available

  • Instituto de Terapias Oncologicas Providencia

    Providencia, Santiago 7501088
    Chile

    Site Not Available

  • Private Office

    Santiago, RM 8360160
    Chile

    Site Not Available

  • Cancer Institute and Hospital ,Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Chinese PLA General Hospital

    Haidian District, Beijing 100853
    China

    Site Not Available

  • The Fuzhou General Hospital, PLA Nanjing Military Area Command

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, Guang DONG 510515
    China

    Site Not Available

  • Urology Department, Sun Yet-Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Nanjing Bayi Hospital

    Nanjing, Jiangsu 210002
    China

    Site Not Available

  • The Oncology Department, Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin 130012
    China

    Site Not Available

  • Urology Department, 1st Hospital of China Medical University

    Shen Yang, LIAO NING 110001
    China

    Site Not Available

  • Xijing Hospital, The Fourth Military Medical University,Oncology Department

    Xi'an, Shaanxi 710032
    China

    Site Not Available

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

    Shanghai, Shanghai 200127
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • Beijing Cancer Hospital/Department of Renal Cancer and Melanoma

    Beijing, 100036
    China

    Site Not Available

  • Department of Urology,Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • South-Western Hospital, 3rd Military Medical University

    Chongqing, 400038
    China

    Site Not Available

  • Jiangsu Cancer Hospital

    Nanjing, 210009
    China

    Site Not Available

  • Fudan University, Cancer Hospital, Department of Urology

    Shanghai, 200032
    China

    Site Not Available

  • Tianjin Oncology Hospital,biology treatment department

    Tianjin, 300060
    China

    Site Not Available

  • Urology Department, The Second Hospital of Tianjin Medical University

    Tianjin, 300211
    China

    Site Not Available

  • BIBI General Hospital and Cancer Centre,

    Hyderabad, Andhra Pradesh 500024
    India

    Site Not Available

  • Chinmaya Mission Hospital

    Bangalore, Karnataka 560038
    India

    Site Not Available

  • NU Hospitals

    Bangalore, Karnataka 560070
    India

    Site Not Available

  • Sri Venkateshwara Hospital

    Bangalore, Karnataka 560068
    India

    Site Not Available

  • Cancer Care Clinic and Hospitals

    Nagpur, Maharashtra 440012
    India

    Site Not Available

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra 422004
    India

    Site Not Available

  • Shatabdi Superspeciality Hospital

    Nashik, Maharashtra 422 005
    India

    Site Not Available

  • Pfizer Investigational Site

    Nasik, Maharashtra 422004
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra 411 004
    India

    Site Not Available

  • Sahyadri Speciality Hospital

    Pune, Maharashtra 411 004
    India

    Site Not Available

  • Shettys hospital

    Bangalore, 560068
    India

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico, DF 14000
    Mexico

    Site Not Available

  • Hospital General de Mexico O.D.

    Mexico City, Distrito Federal 06726
    Mexico

    Site Not Available

  • Centro Hemato-Oncologico Privado

    Toluca, Estado DE Mexico 50080
    Mexico

    Site Not Available

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, 20000
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute

    Quezon City, Diliman
    Philippines

    Site Not Available

  • St. Lukes Medical Center

    Quezon City, Metro Manila 1102
    Philippines

    Site Not Available

  • University of the East Ramon Magsaysay Memorial Medical Center

    Quezon City, Metro Manila 1113
    Philippines

    Site Not Available

  • Pfizer Investigational Site

    Legaspi Village, Makati City, 1200
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati City, 1200
    Philippines

    Site Not Available

  • Room 805, Committee on Research Room, Manila Doctors Hospital

    Manila, 1000
    Philippines

    Site Not Available

  • Oncomed SRL

    Timisoara, JUD. Timis 300239
    Romania

    Site Not Available

  • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Moscow State Healthcare Institution Oncology Clinical Dispensary #1

    Moscow, 105005
    Russian Federation

    Site Not Available

  • P.A. Herzen Moscow Oncology Research Institute,

    Moscow, 125284
    Russian Federation

    Site Not Available

  • FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"

    Ryazan, 390026
    Russian Federation

    Site Not Available

  • GBU RO "Ryazan Regional Clinical Oncology Dispensary"

    Ryazan, 390011
    Russian Federation

    Site Not Available

  • FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

    Ufa, 450054
    Russian Federation

    Site Not Available

  • GVI Oncology

    Port Elizabeth, 6045
    South Africa

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

  • KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,

    Dnipro, 49005
    Ukraine

    Site Not Available

  • MI Dnipropetrovsk Regional Clinical Hospital n a I.I. Mechnikov

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi

    Lviv, 79031
    Ukraine

    Site Not Available

  • SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"

    Zaporizhzhya, 69040
    Ukraine

    Site Not Available

  • Advanced Medical Specialties

    Miami, Florida 33176
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Niles, Illinois 60714
    United States

    Site Not Available

  • Pfizer Investigational Site

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Indiana University Health Central Indiana Cancer Centers

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Indiana University Health Central Indiana Cancer Centers

    Fishers, Indiana 46037
    United States

    Site Not Available

  • Indiana University Health Central Indiana Cancer Centers

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Indiana University Health Central Indiana Cancer Centers

    Indianapolis, Indiana 46227
    United States

    Site Not Available

  • Missouri Cancer Associates

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada 89074
    United States

    Site Not Available

  • US Oncology West Region

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • Hematology-Oncology Associates of Northern NJ, PA

    Parsippany, New Jersey 07054
    United States

    Site Not Available

  • New York Oncology Hematology, PC

    Albany, New York 12208
    United States

    Site Not Available

  • New York Oncology Hematology, PC

    Latham, New York 12110
    United States

    Site Not Available

  • New York Oncology Hematology, PC

    Rexford, New York 12148
    United States

    Site Not Available

  • New York Oncology Hematology, PC

    Troy, New York 12180
    United States

    Site Not Available

  • Raleigh Hematology Oncology Associates

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Northwest Cancer Specialists, PC

    Portland, Oregon 97227
    United States

    Site Not Available

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Oncology- Amarillo

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas 77702-1449
    United States

    Site Not Available

  • Texas Oncology- Bedford

    Bedford, Texas 76022
    United States

    Site Not Available

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Investigational Products Center (lPC)

    Fort Worth, Texas 76177
    United States

    Site Not Available

  • Texas Oncology- Fort Worth 12th Avenue

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Oncology- Southwest Fort Worth

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • US Oncology Research and Clinical Pharmacy

    Fort Worth, Texas 76177
    United States

    Site Not Available

  • Texas Oncology - Grapevine

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Cancer Care Centers of South Texas

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Texas Oncology- McAllen South Second Street

    McAllen, Texas 78503
    United States

    Site Not Available

  • Texas Oncology- Midland Allison Cancer Center

    Midland, Texas 79701
    United States

    Site Not Available

  • Cancer Care Centers of South Texas

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Texas Oncology-Deke Slayton Cancer Center

    Webster, Texas 77598-4420
    United States

    Site Not Available

  • Texas Oncology-Weslaco

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Low Moor, Virginia 24457
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia 24153
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville, Virginia 24382
    United States

    Site Not Available

  • Northwest Cancer Specialists, PC

    Vancouver, Washington 98684
    United States

    Site Not Available

  • Wenatchee Valley Medical Center

    Wenatchee, Washington 98801
    United States

    Site Not Available

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