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

AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER

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.

Study Overview

• Status: Completed
• Conditions: Kidney Neoplasms
• Intervention / Treatment: Drug: Axitinib (AG-013736); Drug: Sorafenib

• Study Type: Interventional
• Enrollment (Actual): 492
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Sorafenib; sorafenib will be given at a dose of 400 mg BID continuous dosing
Experimental: A	Drug: Axitinib (AG-013736); axitinib will be given at a starting dose of 5 mg BID with continuous dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
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.	Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)
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).	Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)
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).	Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants	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).	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)
Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants	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).	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)
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants	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).	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)
Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants	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).	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)
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants	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.	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)
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants	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.	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)
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants	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.	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)
Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2009
• Primary Completion (Actual): July 27, 2012
• Study Completion (Actual): April 29, 2021

Study Registration Dates

• First Submitted: June 11, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib; Axitinib
• Other Study ID Numbers: A4061051; 2010-018585-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.