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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00678392
First received: May 12, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Kidney Neoplasms
Drug: Axitinib (AG-013736)
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Axitinib (Ag-013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Overall survival was defined as the duration from assignment to study treatment to death. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.

  • Percentage of Participants With Objective Response (OR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

  • Duration of Response (DR) [ Time Frame: Week 6, Week 12, every 8 weeks thereafter up to 3 years ] [ Designated as safety issue: No ]
    Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.

  • Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    FKSI was a questionnaire for Functional Assessment of Cancer Therapy (FACT) -Kidney Symptom Index used to assess patient-reported outcomes (PROs) for participants diagnosed with renal cell cancer. The FKSI contained 15 questions. Each question was answered on a five-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 score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).

  • FKSI-Disease Related Symptoms (FKSI-DRS) Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    FKSI-DRS is a subset of FKSI which is a questionnaire for FACT-Kidney Symptom Index used to assess PROs for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0 to 36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.

  • Euro Quality of Life Questionnaires- 5 Dimension (EQ-5D) Index Score [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    EQ-5D was a standardized, PRO measure of health. It provided a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health).

  • EQ-5D Visual Analog Scale (EQ-5D VAS) [ Time Frame: Baseline, Day 1 of every cycle until disease progression and Day 28 of follow-up visit (up to 670 days) ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.


Enrollment: 723
Study Start Date: September 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axitinib Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
Active Comparator: Sorafenib Drug: Sorafenib
sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678392

  Hide Study Locations
Locations
United States, California
Maurice Berkowtiz, MD
Burbank, California, United States, 91505
East Valley Hematology and Oncology Medical Group
Burbank, California, United States, 91505
Agajanian Institute of Oncology and Hematology
Downey, California, United States, 90241
Los Angeles Hematology/Oncology Medical Group
Glendale, California, United States, 91206
Ronald Regan UCLA Medical Center
Loa Angeles, California, United States, 90095
Kenmar Research Institute
Los Angeles, California, United States, 90057
Metropolitan Hematology/Oncology Medical Group
Los Angeles, California, United States, 90057
LAC-USC Medical Center
Los Angeles, California, United States, 90033
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States, 90017
UCLA
Los Angeles, California, United States, 90095
Drug Shipment: USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
USC Norris Cancer Hospital and Clinics
Los Angeles, California, United States, 90033
Agajanian Institute of Oncology and Hematology
Montebello, California, United States, 90640
Brian LeBerthon, MD, A Medical Corporation
West Covina, California, United States, 91790
Agajanian Institute of Oncology and Hematology
Whittier, California, United States, 90606
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80010
University of Colorado Denver: Division of Medical Oncology
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers
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
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Georgetown University Hospital, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Georgetwon University Medical Center (Drug Shipment Address)
Washington, District of Columbia, United States, 2007-2197
United States, Florida
Florida Cancer Specialists
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
University of Miami Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Florida Cancer Specialists
Englewood, Florida, United States, 34223
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists
Fort Myers, Florida, United States, 33908
Florida Cancer Specialists
Fort Myers, Florida, United States, 33905
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Florida Cancer Specialists
Naples, Florida, United States, 34102
Florida Cancer Specialists
Naples, Florida, United States, 34119
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
Florida Cancer Specialists
Port Charlotte, Florida, United States, 33980
Florida Cancer Specialists
Sarasota, Florida, United States, 34236
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Florida Cancer Specialists
Venice, Florida, United States, 34285
Florida Cancer Specialists
Venice, Florida, United States, 34292
United States, Georgia
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30318
Chattanooga Oncology and Hematology Associates, PC
Ringgold, Georgia, United States, 30736
United States, Idaho
Mountain States Tumor Institute
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
United States, Illinois
Loyola University Chicago Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
United States, Indiana
Cental Indiana Cancer Centers
Carmel, Indiana, United States, 46032
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46037
Cental Indiana Cancer Centers
Greenfield, Indiana, United States, 46140
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5948
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
St. John's Mercy, David C. Pratt Cancer Center
St. Louis, Missouri, United States, 63141
St. John's Mercy Medical Center
Washington, Missouri, United States, 63090
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
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
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10466
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center
New York, New York, United States, 10065
Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.
Oneida, New York, United States, 13421
Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.
Oswego, New York, United States, 13126
Suny Upstate Medical University
Syracuse, New York, United States, 13210-2306
Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc
Syracuse, New York, United States, 13210
United States, North Carolina
Raleigh Hematology Oncology Associates, DBA
Cary, North Carolina, United States, 27518
Duke University Medical Center
Durham, North Carolina, United States, 27710
Investigational Chemotherapy Services
Durham, North Carolina, United States, 27710
Virginia Oncology Associates
Elizabeth City, North Carolina, United States, 27909
Albermarie Hospitals
Elizabeth City, North Carolina, United States, 27909
Raleigh Hematology Oncology Associates, P.C.
Raleigh, North Carolina, United States, 27607
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
James Care in Kenny
Columbus, Ohio, United States, 43211
Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, United States, 43210
Ohio State University
Columbus, Ohio, United States, 43210
Monarch
Mayfield Heights, Ohio, United States, 44124
Lake University - Ireland Cancer Center (LUICC)
Mentor, Ohio, United States, 44060
UHHS - Chagrin Highlands
Orange Village, Ohio, United States, 44122
UHHS - Westlake
Westlake, Ohio, United States, 44145
United States, Oregon
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401-8122
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Cancer Centers of the Carolinas
Easley, South Carolina, United States, 29605
Hematology and Oncology Associates of SC, LLC - Eastside Medical Center
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas, Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Chattanooga Oncology Hematology Associates P.C.
Chattanooga, Tennessee, United States, 37404
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Vanderbilt-Ingram Cancer Center-Cool Springs
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
Chattanooga Oncology & Hematology Associates
Hixson, Tennessee, United States, 37343
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37087
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37130
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
Texas Oncology - Central Midtown
Austin, Texas, United States, 78705
Texas Oncology - Austin Northwest
Austin, Texas, United States, 78759
Texas Oncology - Austin Central
Austin, Texas, United States, 78731
Texas Oncolgoy - North Austin
Austin, Texas, United States, 78758
Texas Oncology - South Austin
Austin, Texas, United States, 78745
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Texas Oncology - Cedar Park
Cedar Park, Texas, United States, 78613
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
US Oncology Research and Clinical Pharmacy (drug shipment only
Fort Worth, Texas, United States, 76177
US Oncology Research & Clinical Pharmacy
Fort Worth, Texas, United States, 76177
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, United States, 76177
Investigational Products Centre (IPC)
Fort Worth, Texas, United States, 76177
US Oncology Research & Clinical Pharmacy (drug shipment only)
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC)
Fortworth, Texas, United States, 76177
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Genitourinary Cancer Center
Houston, Texas, United States, 77030
Texas Oncology - Seton Williamson
Round Rock, Texas, United States, 78655
Texas Oncology - Round Rock
Round Rock, Texas, United States, 78681
Texas Oncology, P.A.
Tyler, Texas, United States, 75702
Deke Slayton Cancer Center
Webster, Texas, United States, 77598-4420
Texas Oncology - Clear Lake
Webster, Texas, United States, 77598
United States, Virginia
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22205
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States, 20155
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Virginia Cancer Specialists, PC
Leesburg, Virginia, United States, 20176
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Virginia Cancer Specialists, PC
Woodbridge, Virginia, United States, 22191
United States, Washington
Virginia Mason Medical Center, Section of Hematology/Oncology
Seattle, Washington, United States, 98101
University of Washington Medical Center
Seattle, Washington, United States, 98195
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Australia, Australian Capital Territory
The Canberra Hospital, Medical Oncology
Garran, Australian Capital Territory, Australia, 2605
Australia, South Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Ballarat Oncology & Haematology Services
Ballarat, Victoria, Australia, 3350
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Austin Hospital, Austin Health
Heidelberg, Victoria, Australia, 3084
Heidelberg Repatriation Hospital, Austin Health
Heidelberg West, Victoria, Australia, 3081
Austria
Universitaets-Klinik fuer Innere Medizin I
Wien, Austria, A-1090
Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien
Wien, Austria, 1020
Brazil
Clinica Oncologistas Associados
Rio de Janeiro, RJ, Brazil, 22260-020
Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
Porto Alegre, RS, Brazil, 90050-170
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Fundacao Antonio Prudente
Sao Paulo, SP, Brazil, 01509-900
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, New Brunswick
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
RSM Durham Regional Cancer Centre Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
China, Jiangsu
The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China, Shaanxi
Xijing Hospital, The Fourth Military Medical University,Oncology Department
Xi'an, Shaanxi, China, 710032
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Internal 4 Department
Beijing, China, 100021
Beijing Cancer Hospital
Beijing, China, 100036
Sun Yet-Sen University Cancer Center
Guangzhou, China, 510060
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200127
Tianjin Oncology Hospital,biology treatment department
Tianjin, China, 300060
France
Centre Leon Berard
Lyon, Cedex 08, France, 69373
Hopital Saint-André
Bordeaux Cedex, France, 33075
Hôpital Henri Mondor
CRETEIL Cedex, France, 94010
Institut Paoli-Calmettes
Marseille Cedex 09, France, 13273
Hopital Europeen Georges Pompidou
Paris Cedex 15, France, 75908
Centre Eugene Marquis
Rennes, France, 35042
Centre Rene Gauducheau - Service Oncologie Medicale
St Herblain Cedex, France, 44805
CHRU de Tours - Hopital Bretonneau
Tours Cedex 1, France, 37044
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy / Service d'Immunotherapie
Villejuif Cedex, France, 94805
Germany
RWTH Aachen, Urologische Klinik
Aachen, Germany, 52074
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12200
Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen
Essen, Germany, 45122
Klinikum Region Hannover Krankenhaus Siloah
Hannover, Germany, 30449
Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik
Mainz, Germany, 55131
Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik
Muenchen, Germany, 81377
Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie
Oldenburg, Germany, 26133
Greece
Alexandra University Hospital / Oncology Dept.
Athens, Attiki, Greece, 115 28
"Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology
Thessaloniki, Macedonia, Greece, 540 07
India
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110 029
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682 026
Dept. of Medical Oncology, Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Christian Medical College & Hospital
Ludhiana, Punjab, India, 141 008
Bhagwan Mahaveer Cancer Hospital and Research Center
Jaipur, Rajasthan, India, 302017
Ireland
Oncology Department
Dublin 24, Ireland
Italy
UOC Oncologia Medica, Ospedale San Donato
Arezzo, Italy, 52100
Dipartimento dei laboratori diagnositici e per le terapie cellulari
Aviano, Italy, 33081
Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS
Aviano (PN), Italy, 33081
Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica
Brescia, Italy, 25123
Struttura Complessa di Oncologia
Cremona, Italy, 26100
UOC Oncologia Medica B, IRCCS AO Universitaria San Martino
Genova, Italy, 16132
Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2
Milano, Italy, 20133
Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
Napoli, Italy, 80131
Divisione di Oncologia, AORN Antonio Cardarelli
Napoli, Italy, 80131
Unita' Operativa Oncologia Medica 2, Regione del Veneto
Padova, Italy, 35128
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Struttura Complessa di Oncologia Medica A
Roma, Italy, 00144
Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano
Roma, Italy, 00152
UO di Oncologia ed Ematologia, Istituto Clinico Humanitas
Rozzano (MI), Italy, 20089
Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638
Sapporo Medical University School of Medicine, Department of Urology
Sapporo, Hokkaido, Japan, 0608543
University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology
Tsukuba, Ibaraki, Japan, 305-8577
Kinki University Hospital
Osakasayama, Osaka, Japan, 589-8511
Hamamatsu University School of Medicine
Hamamatsu-City, Shizuoka, Japan, 431-3192
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Tokyo Women's Medical University Medical Center East, Department of Urology
Arakawa-ku, Tokyo, Japan, 116-8567
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan, 755-8505
Akita University Hospital
Akita, Japan, 010-8543
Chiba Cancer Center
Chiba, Japan, 260-8717
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Tokushima University
Tokushima, Japan, 770-8503
Yamagata University Hospital
Yamagata, Japan, 990-9585
Korea, Republic of
National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology
Busan, Korea, Republic of, 602-715
Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology
Seoul, Korea, Republic of, 137-701
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Severance Hospital
Seoul, Korea, Republic of, 120-752
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Poland
Wojewodzkie Centrum Onkologii
Gdansk, Poland, 80-210
Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, Poland, 61-878
Klinika Onkologii, Wojskowy Instytut Medyczny
Warszawa, Poland, 00-909
Klinika Urologii i Onkologii Urologicznej
Wroclaw, Poland, 50-556
Russian Federation
Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
Obninsk, Kaluga region, Russian Federation, 249036
Moscow Research Institute of Oncology P.A. Herzen
Moscow, Russian Federation, 125284
Cancer Research Center named after N.N. Blokhin, Biotherapy Department
Moscow, Russian Federation, 115478
Russian Research Center of Roentgenology and Radiology
Moscow, Russian Federation, 117997
Cancer Research Center named after N.N.Blokhin, Chemotherapy Department
Moscow, Russian Federation, 115478
The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation
Moscow, Russian Federation, 123060
City Clinical Oncology Dispensary
St. Petersburg, Russian Federation, 198255
Singapore
National Cancer Centre
Singapore, Singapore, 169610
Slovakia
Narodny Onkologicky ustav
Bratislava, Slovakia, 833 10
Onkologicky Ustav sv. Alzbety
Bratislava, Slovakia, 812 50
Nemocnica s poliklinikou Zilina
Zilina, Slovakia, 012 07
Spain
Institut Catala D'Oncologia L'Hospitalet
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clinico Universitario Virgen de La Victoria
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sweden
Universitetssjukhuset, Onkologiska kliniken
Linkoping, Sweden, 581 85
Norrlands Universitetssjukhus, Onkologkliniken
Umea, Sweden, 901 85
Onkologkliniken
Vaxjo, Sweden, 351 85
Taiwan
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung Hsien, Taiwan, 833
Taichung Veterans General Hospital, Department of Surgery
Taichung, Taiwan, 407
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
United Kingdom
Royal Marsden Hospital
London, England, United Kingdom, SW3 6JJ
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Clatterbridge Centre for Oncology NHS Foundation Trust
Bebington, Wirral, United Kingdom, CH63 4JY
University of Birmingham, CRUK Institute for Cancer Studies
Birmingham, United Kingdom, B15 2TT
Royal Bournemouth & Poole Hospitals
Bournemouth, United Kingdom, SO41 3QS
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Addenbrooke`s Hospital
Cambridge, United Kingdom, CB2 0QQ
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YH
Department of Medical Oncology, St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
University Department of Medical Oncology/Oxford Cancer Centre
Oxford, United Kingdom, OX3 7LJ
Royal Marsden Hospital NHS Foundation Trust
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00678392     History of Changes
Other Study ID Numbers: A4061032, AXIS TRIAL, 2008-001451-21, AXIS
Study First Received: May 12, 2008
Results First Received: February 25, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Axitinib in Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Axitinib
Sorafenib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014