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

Kidney Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920816
• Other study ID #: A4061051
• Secondary ID: 2010-018585-23
• Status: Completed
• Phase: Phase 3
• Start date: August 25, 2009
• Est. completion date: April 29, 2021

Study information

• Verified date: April 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: April 29, 2021
• Est. primary completion date: July 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Drug:
• Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
• Sorafenib
sorafenib will be given at a dose of 400 mg BID continuous dosing

Locations

Country	Name	City	State
Bosnia and Herzegovina	Clinic of Oncology	Banja Luka
Bosnia and Herzegovina	Institute of Oncology, University Hospital Center Sarajevo	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla, Clinic for Oncology, Hematology and Radiotherapy	Tuzla
Bulgaria	Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, EAD, Klinika po Himioterapiya	Sofia
Bulgaria	SBALOZ D-r Marko Markov-Varna	Varna
Chile	Instituto de Terapias Oncologicas Providencia	Providencia	Santiago
Chile	Private Office	Santiago
Chile	Instituto Clinico Oncologico del Sur	Temuco	Cautin
Chile	Instituto Clinico Oncologico del Sur	Temuco	IX Region
China	Beijing Cancer Hospital/Department of Renal Cancer and Melanoma	Beijing
China	Cancer Institute and Hospital ,Chinese Academy of Medical Sciences	Beijing	Beijing
China	Department of Urology,Peking University First Hospital	Beijing
China	Jilin Provincial Cancer Hospital	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	South-Western Hospital, 3rd Military Medical University	Chongqing
China	The Fuzhou General Hospital, PLA Nanjing Military Area Command	Fuzhou	Fujian
China	Nanfang Hospital	Guangzhou	Guang DONG
China	Urology Department, Sun Yet-Sen University Cancer Center	Guangzhou	Guangdong
China	Chinese PLA General Hospital	Haidian District	Beijing
China	Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing
China	Nanjing Bayi Hospital	Nanjing	Jiangsu
China	The Oncology Department, Jiangsu Province Hospital	Nanjing	Jiangsu
China	Fudan University, Cancer Hospital, Department of Urology	Shanghai
China	Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Urology Department, 1st Hospital of China Medical University	Shen Yang	LIAO NING
China	Tianjin Oncology Hospital,biology treatment department	Tianjin
China	Urology Department, The Second Hospital of Tianjin Medical University	Tianjin
China	Xijing Hospital, The Fourth Military Medical University,Oncology Department	Xi'an	Shaanxi
India	Chinmaya Mission Hospital	Bangalore	Karnataka
India	NU Hospitals	Bangalore	Karnataka
India	Shettys hospital	Bangalore
India	Sri Venkateshwara Hospital	Bangalore	Karnataka
India	BIBI General Hospital and Cancer Centre,	Hyderabad	Andhra Pradesh
India	Cancer Care Clinic and Hospitals	Nagpur	Maharashtra
India	Curie Manavata Cancer Centre	Nashik	Maharashtra
India	Shatabdi Superspeciality Hospital	Nashik	Maharashtra
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
India	Sahyadri Speciality Hospital	Pune	Maharashtra
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Mexico	Centenario Hospital Miguel Hidalgo	Aguascalientes
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico	DF
Mexico	Hospital General de Mexico O.D.	Mexico City	Distrito Federal
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Centro Hemato-Oncologico Privado	Toluca	Estado DE Mexico
Philippines	Makati Medical Center	Makati City
Philippines	Room 805, Committee on Research Room, Manila Doctors Hospital	Manila
Philippines	Rm. 3227 Doctors Clinic, Annex II Bldg., National Kidney & Transplant Institute	Quezon City	Diliman
Philippines	St. Lukes Medical Center	Quezon City	Metro Manila
Philippines	University of the East Ramon Magsaysay Memorial Medical Center	Quezon City	Metro Manila
Romania	Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj-Napoca	Cluj-Napoca
Romania	Institutul Oncologic ''Prof.Dr. I. Chiricuta'' Cluj Napoca	Cluj-Napoca
Romania	Oncomed SRL	Timisoara	JUD. Timis
Russian Federation	Moscow State Healthcare Institution Oncology Clinical Dispensary #1	Moscow
Russian Federation	P.A. Herzen Moscow Oncology Research Institute,	Moscow
Russian Federation	FGBOU VO "Ryazan State Medical University named after academician I.P.Pavlov"	Ryazan
Russian Federation	GBU RO "Ryazan Regional Clinical Oncology Dispensary"	Ryazan
Russian Federation	FGBOU VO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"	Saint-Petersburg
Russian Federation	Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic	Ufa
South Africa	GVI Oncology	Port Elizabeth
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
Ukraine	KP Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova" Dnipropetrovskoi oblasnoi rady,	Dnipro
Ukraine	Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasnyi medychnyi klinichnyi tsentr	Kharkiv
Ukraine	DU Instytut Urolohii NAMN Ukrainy, viddil onkourolohii, KNP Kyivskyi miskyi klinichnyi onkolohichnyi	Kyiv
Ukraine	Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi rehionalnyi	Lviv
Ukraine	SI "Zaporizhzhya Medical Academy of Postgraduate Education of the Ministry of Health of Ukraine"	Zaporizhzhya
United States	New York Oncology Hematology, PC	Albany	New York
United States	New York Oncology Hematology, PC	Albany	New York
United States	Texas Oncology- Amarillo	Amarillo	Texas
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Texas Oncology- Bedford	Bedford	Texas
United States	Indiana University Health Central Indiana Cancer Centers	Carmel	Indiana
United States	Raleigh Hematology Oncology Associates	Cary	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina University Hospital	Charleston	South Carolina
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Christiansburg	Virginia
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Texas Oncology- Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Indiana University Health Central Indiana Cancer Centers	Fishers	Indiana
United States	Investigational Products Center (lPC)	Fort Worth	Texas
United States	Texas Oncology- Fort Worth 12th Avenue	Fort Worth	Texas
United States	Texas Oncology- Southwest Fort Worth	Fort Worth	Texas
United States	US Oncology Research and Clinical Pharmacy	Fort Worth	Texas
United States	Texas Oncology - Grapevine	Grapevine	Texas
United States	Indiana University Health Central Indiana Cancer Centers	Greenfield	Indiana
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	US Oncology West Region	Henderson	Nevada
United States	Penn State Milton S. Hershey Medical Center, Penn State Cancer Institute	Hershey	Pennsylvania
United States	Indiana University Health Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Indiana University Health Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Cancer Care Centers of South Texas	Kerrville	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	New York Oncology Hematology, PC	Latham	New York
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Low Moor	Virginia
United States	Texas Oncology- McAllen South Second Street	McAllen	Texas
United States	Advanced Medical Specialties	Miami	Florida
United States	Advanced Medical Specialties	Miami	Florida
United States	Texas Oncology- Midland Allison Cancer Center	Midland	Texas
United States	Hematology-Oncology Associates of Northern NJ, PA	Morristown	New Jersey
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Hematology-Oncology Associates of Northern NJ, PA	Parsippany	New Jersey
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Northwest Cancer Specialists, PC	Portland	Oregon
United States	Raleigh Hematology Oncology Associates	Raleigh	North Carolina
United States	Raleigh Hematology Oncology Associates	Raleigh	North Carolina
United States	New York Oncology Hematology, PC	Rexford	New York
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Roanoke	Virginia
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Salem	Virginia
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	New York Oncology Hematology, PC	Troy	New York
United States	Northwest Cancer Specialists, PC	Tualatin	Oregon
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Texas Oncology-Deke Slayton Cancer Center	Webster	Texas
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Texas Oncology-Weslaco	Weslaco	Texas
United States	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Bulgaria,  Chile,  China,  India,  Malaysia,  Mexico,  Philippines,  Romania,  Russian Federation,  South Africa,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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