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

Primary Purpose

Kidney Neoplasms

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Axitinib (AG-013736)
Sorafenib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms focused on measuring Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Advanced Medical Specialties
  • Advanced Medical Specialties
  • Illinois Cancer Specialists
  • Illinois Cancer Specialists
  • Indiana University Health Central Indiana Cancer Centers
  • Indiana University Health Central Indiana Cancer Centers
  • Indiana University Health Central Indiana Cancer Centers
  • Indiana University Health Central Indiana Cancer Centers
  • Indiana University Health Central Indiana Cancer Centers
  • Missouri Cancer Associates
  • Nebraska Methodist Hospital
  • Comprehensive Cancer Centers of Nevada
  • US Oncology West Region
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Centers of Nevada
  • Hematology-Oncology Associates of Northern NJ, PA
  • Hematology-Oncology Associates of Northern NJ, PA
  • New York Oncology Hematology, PC
  • New York Oncology Hematology, PC
  • New York Oncology Hematology, PC
  • New York Oncology Hematology, PC
  • New York Oncology Hematology, PC
  • Raleigh Hematology Oncology Associates
  • Raleigh Hematology Oncology Associates
  • Raleigh Hematology Oncology Associates
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
  • Medical University of South Carolina University Hospital
  • Medical University of South Carolina
  • Texas Oncology- Amarillo
  • Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
  • Texas Oncology- Bedford
  • Texas Oncology- Baylor Charles A. Sammons Cancer Center
  • Texas Oncology- Fort Worth 12th Avenue
  • Texas Oncology- Southwest Fort Worth
  • Investigational Products Center (lPC)
  • US Oncology Research and Clinical Pharmacy
  • Texas Oncology - Grapevine
  • Cancer Care Centers of South Texas
  • Texas Oncology- McAllen South Second Street
  • Texas Oncology- Midland Allison Cancer Center
  • Cancer Care Centers of South Texas
  • Cancer Care Centers of South Texas
  • Texas Oncology-Deke Slayton Cancer Center
  • Texas Oncology-Weslaco
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Northwest Cancer Specialists, PC
  • Northwest Cancer Specialists, PC
  • Wenatchee Valley Medical Center
  • Clinic of Oncology
  • Institute of Oncology, University Hospital Center Sarajevo
  • University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
  • Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
  • SBALOZ D-r Marko Markov-Varna
  • Instituto Clinico Oncologico del Sur
  • Instituto Clinico Oncologico del Sur
  • Instituto de Terapias Oncologicas Providencia
  • Private Office
  • Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
  • Chinese PLA General Hospital
  • The Fuzhou General Hospital, PLA Nanjing Military Area Command
  • Nanfang Hospital
  • Urology Department, Sun Yet-Sen University Cancer Center
  • Nanjing Bayi Hospital
  • The Oncology Department, Jiangsu Province Hospital
  • Jilin Provincial Cancer Hospital
  • Urology Department, 1st Hospital of China Medical University
  • Xijing Hospital, The Fourth Military Medical University,Oncology Department
  • Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
  • West China Hospital of Sichuan University
  • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
  • Department of Urology,Peking University First Hospital
  • Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
  • South-Western Hospital, 3rd Military Medical University
  • Jiangsu Cancer Hospital
  • Fudan University, Cancer Hospital, Department of Urology
  • Tianjin Oncology Hospital,biology treatment department
  • Urology Department, The Second Hospital of Tianjin Medical University
  • BIBI General Hospital and Cancer Centre,
  • Chinmaya Mission Hospital
  • Sri Venkateshwara Hospital
  • NU Hospitals
  • Cancer Care Clinic and Hospitals
  • Shatabdi Superspeciality Hospital
  • Curie Manavata Cancer Centre
  • Deenanath Mangeshkar Hospital and Research Centre
  • Sahyadri Speciality Hospital
  • Shettys hospital
  • University Malaya Medical Centre
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Hospital General de Mexico O.D.
  • Centro Hemato-Oncologico Privado
  • Centenario Hospital Miguel Hidalgo
  • Oaxaca Site Management Organization
  • Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute
  • St. Lukes Medical Center
  • University of the East Ramon Magsaysay Memorial Medical Center
  • Makati Medical Center
  • Room 805, Committee on Research Room, Manila Doctors Hospital
  • Oncomed SRL
  • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca
  • Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
  • Moscow State Healthcare Institution Oncology Clinical Dispensary #1
  • P.A. Herzen Moscow Oncology Research Institute,
  • GBU RO "Ryazan Regional Clinical Oncology Dispensary"
  • FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"
  • FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
  • Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
  • GVI Oncology
  • Taichung Veterans General Hospital
  • Taipei Veterans General Hospital
  • KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,
  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr
  • DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi
  • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi
  • SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS): First-Line Participants
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 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
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
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 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 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 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 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).

Full Information

First Posted
June 11, 2009
Last Updated
April 9, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00920816
Brief Title
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Official Title
AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2009 (Actual)
Primary Completion Date
July 27, 2012 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms
Keywords
Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
492 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Axitinib (AG-013736)
Intervention Description
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
sorafenib will be given at a dose of 400 mg BID continuous dosing
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS): First-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Title
Progression Free Survival (PFS): Second-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR): First-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Title
Percentage of Participants With Objective Response (OR): Second-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Title
Duration of Response (DR): First-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Title
Duration of Response (DR): Second-Line Participants
Description
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.
Time Frame
Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Title
Overall Survival (OS): First-Line Participants
Description
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).
Time Frame
Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
Title
Overall Survival (OS): Second-Line Participants
Description
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).
Time Frame
Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
Other Pre-specified Outcome Measures:
Title
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants
Description
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).
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)
Title
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants
Description
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).
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)
Title
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants
Description
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).
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)
Title
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants
Description
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).
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)
Title
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants
Description
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.
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)
Title
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants
Description
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.
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)
Title
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants
Description
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.
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)
Title
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Indiana University Health Central Indiana Cancer Centers
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University Health Central Indiana Cancer Centers
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Facility Name
Indiana University Health Central Indiana Cancer Centers
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Indiana University Health Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Indiana University Health Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
US Oncology West Region
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Hematology-Oncology Associates of Northern NJ, PA
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Hematology-Oncology Associates of Northern NJ, PA
City
Parsippany
State/Province
New Jersey
ZIP/Postal Code
07054
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Rexford
State/Province
New York
ZIP/Postal Code
12148
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Troy
State/Province
New York
ZIP/Postal Code
12180
Country
United States
Facility Name
Raleigh Hematology Oncology Associates
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Raleigh Hematology Oncology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Raleigh Hematology Oncology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27614
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Medical University of South Carolina University Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology- Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1449
Country
United States
Facility Name
Texas Oncology- Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology- Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology- Fort Worth 12th Avenue
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology- Southwest Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Investigational Products Center (lPC)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
US Oncology Research and Clinical Pharmacy
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Texas Oncology - Grapevine
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Texas Oncology- McAllen South Second Street
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology- Midland Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258-3912
Country
United States
Facility Name
Texas Oncology-Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4420
Country
United States
Facility Name
Texas Oncology-Weslaco
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Wytheville
State/Province
Virginia
ZIP/Postal Code
24382
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Clinic of Oncology
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Institute of Oncology, University Hospital Center Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
SBALOZ D-r Marko Markov-Varna
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Instituto Clinico Oncologico del Sur
City
Temuco
State/Province
Cautin
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Instituto Clinico Oncologico del Sur
City
Temuco
State/Province
IX Region
ZIP/Postal Code
4810561
Country
Chile
Facility Name
Instituto de Terapias Oncologicas Providencia
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7501088
Country
Chile
Facility Name
Private Office
City
Santiago
ZIP/Postal Code
RM 8360160
Country
Chile
Facility Name
Cancer Institute and Hospital ,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Chinese PLA General Hospital
City
Haidian District
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Fuzhou General Hospital, PLA Nanjing Military Area Command
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guang DONG
ZIP/Postal Code
510515
Country
China
Facility Name
Urology Department, Sun Yet-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Nanjing Bayi Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
The Oncology Department, Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Jilin Provincial Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Urology Department, 1st Hospital of China Medical University
City
Shen Yang
State/Province
LIAO NING
ZIP/Postal Code
110001
Country
China
Facility Name
Xijing Hospital, The Fourth Military Medical University,Oncology Department
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Department of Urology,Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Cancer Hospital/Department of Renal Cancer and Melanoma
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
South-Western Hospital, 3rd Military Medical University
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Fudan University, Cancer Hospital, Department of Urology
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tianjin Oncology Hospital,biology treatment department
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Urology Department, The Second Hospital of Tianjin Medical University
City
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
BIBI General Hospital and Cancer Centre,
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500024
Country
India
Facility Name
Chinmaya Mission Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560038
Country
India
Facility Name
Sri Venkateshwara Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560068
Country
India
Facility Name
NU Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560070
Country
India
Facility Name
Cancer Care Clinic and Hospitals
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Shatabdi Superspeciality Hospital
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Curie Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Shettys hospital
City
Bangalore
ZIP/Postal Code
560068
Country
India
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital General de Mexico O.D.
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Centro Hemato-Oncologico Privado
City
Toluca
State/Province
Estado DE Mexico
ZIP/Postal Code
50080
Country
Mexico
Facility Name
Centenario Hospital Miguel Hidalgo
City
Aguascalientes
ZIP/Postal Code
20000
Country
Mexico
Facility Name
Oaxaca Site Management Organization
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute
City
Quezon City
State/Province
Diliman
Country
Philippines
Facility Name
St. Lukes Medical Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1102
Country
Philippines
Facility Name
University of the East Ramon Magsaysay Memorial Medical Center
City
Quezon City
State/Province
Metro Manila
ZIP/Postal Code
1113
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Room 805, Committee on Research Room, Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Oncomed SRL
City
Timisoara
State/Province
JUD. Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Moscow State Healthcare Institution Oncology Clinical Dispensary #1
City
Moscow
ZIP/Postal Code
105005
Country
Russian Federation
Facility Name
P.A. Herzen Moscow Oncology Research Institute,
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
GBU RO "Ryazan Regional Clinical Oncology Dispensary"
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
GVI Oncology
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"
City
Zaporizhzhya
ZIP/Postal Code
69040
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
33947608
Citation
Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
Results Reference
derived
PubMed Identifier
28410911
Citation
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.
Results Reference
derived
PubMed Identifier
27498023
Citation
Hutson TE, Al-Shukri S, Stus VP, Lipatov ON, Shparyk Y, Bair AH, Rosbrook B, Andrews GI, Vogelzang NJ. Axitinib Versus Sorafenib in First-Line Metastatic Renal Cell Carcinoma: Overall Survival From a Randomized Phase III Trial. Clin Genitourin Cancer. 2017 Feb;15(1):72-76. doi: 10.1016/j.clgc.2016.05.008. Epub 2016 May 27.
Results Reference
derived
PubMed Identifier
27238653
Citation
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.
Results Reference
derived
PubMed Identifier
26089686
Citation
Qin S, Bi F, Jin J, Cheng Y, Guo J, Ren X, Huang Y, Tarazi J, Tang J, Chen C, Kim S, Ye D. Axitinib versus sorafenib as a second-line therapy in Asian patients with metastatic renal cell carcinoma: results from a randomized registrational study. Onco Targets Ther. 2015 Jun 8;8:1363-73. doi: 10.2147/OTT.S83302. eCollection 2015.
Results Reference
derived
PubMed Identifier
24206640
Citation
Hutson TE, Lesovoy V, Al-Shukri S, Stus VP, Lipatov ON, Bair AH, Rosbrook B, Chen C, Kim S, Vogelzang NJ. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1287-94. doi: 10.1016/S1470-2045(13)70465-0. Epub 2013 Oct 25.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061051&StudyName=Axitinib%20%28AG-013736%29%20For%20the%20Treatment%20of%20Metastatic%20Renal%20Cell%20Cancer
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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