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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
First received: June 11, 2009
Last updated: October 11, 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.


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: Ag-013736 (Axitinib) For The Treatment Of Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival (PFS): First-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ] [ Designated as safety issue: No ]
    Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.

  • Progression Free Survival (PFS): Second-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ] [ Designated as safety issue: No ]
    Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was "Death"). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.


Secondary Outcome Measures:
  • Percentage of Participants With Objective Response (OR): First-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ] [ Designated as safety issue: No ]
    Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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.

  • Percentage of Participants With Objective Response (OR): Second-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ] [ Designated as safety issue: No ]
    Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to 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): First-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ] [ Designated as safety issue: No ]
    Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  • Duration of Response (DR): Second-Line Participants [ Time Frame: Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ] [ Designated as safety issue: No ]
    Time in months from the first documentation of objective tumor response that is subsequently confirmed 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 any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  • Overall Survival (OS): First-Line Participants [ Time Frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107) ] [ Designated as safety issue: No ]
    Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization 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).

  • Overall Survival (OS): Second-Line Participants [ Time Frame: Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103) ] [ Designated as safety issue: No ]
    Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization 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).


Other Outcome Measures:
  • Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).

  • Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).

  • Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).

  • Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    FKSI-DRS: subset of FKSI which is FACT-Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).

  • Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  • Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose) ] [ 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.

  • Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants [ Time Frame: Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose) ] [ 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: 492
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
Active Comparator: B Drug: Sorafenib
sorafenib will be given at a dose of 400 mg BID continuous dosing

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
  • Major surgery less that 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: NCT00920816

  Hide Study Locations
Locations
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
Advanced Medical Specialities
Miami, Florida, United States, 33143
United States, Illinois
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, United States, 60005
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
Cancer Care & Hematology Specialists of Chicagoland
Winfield, Illinois, United States, 60190
United States, Indiana
Central Indiana Cancer Centers
Carmel, Indiana, United States, 46032
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46037
Central 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, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
US Oncology West Region
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Hematology-Oncology Associates of Northern NJ, PA
Morristown, New Jersey, United States, 07962
Hematology-Oncology Associates of Northern NJ, PA
Parsippany, New Jersey, United States, 07054
United States, New York
New York Oncology Hematology, PC
Albany, New York, United States, 12208
New York Oncology Hematology, PC
Albany, New York, United States, 12206
New York Oncology Hematology, PC
Latham, New York, United States, 12110
New York Oncology Hematology, PC
Rexford, New York, United States, 12148
New York Oncology Hematology, PC
Troy, New York, United States, 12180
United States, North Carolina
Raleigh Hematology Oncology Associates
Cary, North Carolina, United States, 27518
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27614
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27607
United States, Oregon
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97213
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97225
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Oncology- Amarillo
Amarillo, Texas, United States, 79106
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702-1449
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology- Fort Worth 12th Avenue
Fort Worth, Texas, United States, 76104
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
Texas Oncology- Southwest Fort Worth
Fort Worth, Texas, United States, 76132
US Oncology Research and Clinical Pharmacy
Fort Worth, Texas, United States, 76177
Cancer Care Centers of South Texas
Kerrville, Texas, United States, 78028
Texas Oncology- McAllen South Second Street
McAllen, Texas, United States, 78503
Texas Oncology- Midland Allison Cancer Center
Midland, Texas, United States, 79701
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78258-3912
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, United States, 77598-4420
Texas Oncology-Weslaco
Weslaco, Texas, United States, 78596
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Christiansburg, Virginia, United States, 24073
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
United States, Washington
Northwest Cancer Specialists, PC
Vancouver, Washington, United States, 98684
Northwest Cancer Specialists, PC
Vancouver, Washington, United States, 98686
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
Bosnia and Herzegovina
Clinic of Oncology
Banja Luka, Bosnia and Herzegovina, 78000
Institute of Oncology, University Hospital Center Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
Tuzla, Bosnia and Herzegovina, 75000
Bulgaria
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
Sofia, Bulgaria, 1756
SBALOZ D-r Marko Markov-Varna
Varna, Bulgaria, 9000
Chile
Instituto Clinico Oncologico del Sur
Temuco, Cautin, Chile, 4810469
Instituto de Terapias Oncologicas Providencia
Providencia, Santiago, RM, Chile, 7501088
QUALIMED
Santiago, RM, Chile, 7500710
China, Fujian
Department of Oncology, The Fuzhou General Hospital, PLA Nanjing Military Area Command
FuZhou, Fujian, China, 350025
China, Guangdong
Urology Department, Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Jiangsu
The Oncology Department
Nanjing, Jiangsu, China, 210029
The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China, Jilin
Department of Oncology, Jilin Province Cancer Hospital
Changchun, Jilin, China, 130012
China, Shanghai
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200127
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
Hangzhou, Zhejiang, China, 310016
China
Department of Oncology, Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
Beijing, China, 100021
Department of Urology,Peking University First Hospital
Beijing, China, 100034
Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
Beijing, China, 100036
Chinese PLA General Hospital
Beijing, China, 100853
South-Western Hospital, 3rd Military Medical University
Chongqing, China, 400038
Nanfang Hospital
Guangzhou, China, 510515
Jiangsu Cancer Hospital/Dept. of Internal Medicine
Nanjing, China, 210009
Fudan University, Cancer Hospital, Department of Urology
Shanghai, China, 200032
The Urology Department, The First Affiliated Hospital, China Medical University
Shen Yang, China, 110001
Urology Department, The Second Hospital of Tianjin Medical University
Tianjin, China, 300211
Tianjin Oncology Hospital,biology treatment department
Tianjin, China, 300060
Xijing Hospital, The Fourth Military Medical University,Oncology Department
Xi'an, China, 710032
India
BIBI General Hospital and Cancer Centre,
Hyderabad, Andhra Pradesh, India, 500024
NU Hospitals
Bangalore, Karnataka, India, 560070
Sri Venkateshwara Hospital
Bangalore, Karnataka, India, 560068
Chinmaya Mission Hospital
Bangalore, Karnataka, India, 560038
Cancer Care Clinic and Hospital
Nagpur, Maharashtra, India, 440012
Shatabdi Superspeciality Hospital
Nashik, Maharashtra, India, 422 005
Curie Manavata Cancer Centre
Nasik, Maharashtra, India, 422004
Sahyadri Clinical Research and Development Center,
Pune, Maharashtra, India, 411 004
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India, 411 004
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, DF, Mexico, 14000
Hospital General de Mexico O.D.
Mexico City, Distrito Federal, Mexico, 06726
Centro Hemato-Oncologico Privado
Toluca, Estado de Mexico, Mexico, 50080
Centenario Hospital Miguel Hidalgo
Aguascalientes, Mexico, 20000
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Philippines
National Kidney and Transplant Institute
Quezon City, Diliman, Philippines
Makati Medical Center
Makati City, Philippines, 1200
Room 805, Committee on Research Room, Manila Doctors Hospital
Manila, Philippines, 1000
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, Philippines
St. Luke's Medical Center
Quezon City, Philippines, 1102
Romania
Oncomed SRL
Timisoara, Jud. Timis, Romania, 300239
Institutul Oncologic "Prof.Dr.I.Chiricuta"
Cluj-Napoca, Romania, 400015
Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
Cluj-Napoca, Romania, 400015
Russian Federation
Moscow State Healthcare Institution Oncology Clinical Dispensary #1, affiliate
Moscow, Russian Federation, 111033
FSI "Moscow Scientific-research Oncology Institute P.A. Herzen" Minzdravsocrazvitiya Rossii
Moscow, Russian Federation, 125284
Moscow State Healthcare Institution Oncology Clinical Dispensary #1
Moscow, Russian Federation, 105005
State Healthcare Institution Ryazan Regional Clinical Oncology Dispensary
Ryazan, Russian Federation, 390011
State educational institution of higher professional education
Ryazan, Russian Federation, 390026
Saint-Petersburg State Medical University I.P.Pavlov / Chair of Urology
Saint-Petersburg, Russian Federation, 197022
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
Ufa, Russian Federation, 450054
South Africa
GVI Oncology
Port Elizabeth, South Africa, 6045
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Ukraine
MI Dnipropetrovsk Regional Clinical Hospital n a I.I. Mechnikov
Dnipropetrovsk, Ukraine, 49005
Kharkiv Regional Clinical Center of Urology and Nephrology
Kharkiv, Ukraine, 61037
Kyiv City Clinical Oncologic Center
Kyiv, Ukraine, 03115
State Enterprise "Institute of Urology of AMS of Ukraine"
Kyiv, Ukraine, 04053
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
Zaporizhzhia Regional Clinical Oncology Dispensary
Zaporizhzhya, Ukraine, 69040
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: NCT00920816     History of Changes
Other Study ID Numbers: A4061051, 2010-018585-23
Study First Received: June 11, 2009
Results First Received: July 26, 2013
Last Updated: October 11, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014