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

Kidney Neoplasms Clinical Trial

Official title:

AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678392
• Other study ID #: A4061032
• Secondary ID: AXIS TRIAL2008-0
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2008
• Est. completion date: February 25, 2016

Study information

• Verified date: December 2018
• 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 after failure of one first line regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 723
• Est. completion date: February 25, 2016
• Est. primary completion date: August 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis

• Evidence of measurable disease

• Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

• Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy

• Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

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 twice daily [BID] with continuous dosing
• Sorafenib
sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing

Locations

Country	Name	City	State
Australia	Ballarat Oncology & Haematology Services	Ballarat	Victoria
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	The Canberra Hospital, Medical Oncology	Garran	Australian Capital Territory
Australia	Austin Hospital, Austin Health	Heidelberg	Victoria
Australia	Heidelberg Repatriation Hospital, Austin Health	Heidelberg West	Victoria
Australia	Ashford Cancer Centre Research	Kurralta Park	South Australia
Austria	Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien	Wien
Austria	Universitaets-Klinik fuer Innere Medizin I	Wien
Brazil	Fundacao Pio XII Hospital de Cancer de Barretos	Barretos	SP
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita	Porto Alegre	RS
Brazil	Clinica Oncologistas Associados	Rio de Janeiro	RJ
Brazil	Fundacao Antonio Prudente	Sao Paulo	SP
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	British Columbia Cancer Agency - Cancer Centre for the Southern Interior	Kelowna	British Columbia
Canada	Dr. Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	RSM Durham Regional Cancer Centre Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
China	Beijing Cancer Hospital	Beijing	P.R.
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Chaoyang District
China	Sun Yet-Sen University Cancer Center	Guangzhou
China	The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital	Nanjing	Jiangsu
China	Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine	Shanghai
China	Tianjin Oncology Hospital,biology treatment department	Tianjin
China	Xijing Hospital, The Fourth Military Medical University	Xi'an	Shaanxi
France	Hopital Saint-André	Bordeaux Cedex
France	Hôpital Henri Mondor	CRETEIL Cedex
France	Centre Leon Berard	Lyon	Cedex 08
France	Institut Paoli-Calmettes	Marseille Cedex 09
France	Hopital Europeen Georges Pompidou	Paris Cedex 15
France	Centre Eugene Marquis	Rennes
France	Centre Rene Gauducheau - Service Oncologie Medicale	St Herblain Cedex
France	CHRU de Tours - Hopital Bretonneau	Tours Cedex 1
France	Centre Alexis Vautrin	Vandoeuvre les Nancy
France	Institut Gustave Roussy / Service d'Immunotherapie	Villejuif Cedex
Germany	RWTH Aachen, Urologische Klinik	Aachen
Germany	Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen	Essen
Germany	Klinikum Region Hannover Krankenhaus Siloah	Hannover
Germany	Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik	Mainz
Germany	Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik	Muenchen
Germany	Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie	Oldenburg
Greece	Alexandra University Hospital / Oncology Dept.	Athens	Attiki
Greece	"Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology	Thessaloniki	Macedonia
India	Fortis Memorial Research Institute	Gurgaon	Haryana
India	Bhagwan Mahaveer Cancer Hospital and Research Center	Jaipur	Rajasthan
India	Amrita Institute of Medical Sciences	Kochi	Kerala
India	Christian Medical College & Hospital	Ludhiana	Punjab
India	Dept. of Medical Oncology, Tata Memorial Hospital	Mumbai	Maharashtra
Ireland	Oncology Department	Dublin 24
Italy	UOC Oncologia Medica, Ospedale San Donato	Arezzo
Italy	Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS	Aviano (PN)
Italy	Dipartimento dei laboratori diagnositici e per le terapie cellulari	Aviano (PN)
Italy	Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica	Brescia
Italy	Struttura Complessa di Oncologia	Cremona
Italy	UOC Oncologia Medica B, IRCCS AO Universitaria San Martino	Genova
Italy	Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2	Milano
Italy	Divisione di Oncologia, AORN Antonio Cardarelli	Napoli
Italy	Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale	Napoli
Italy	Unita' Operativa Oncologia Medica 2, Regione del Veneto	Padova
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano	Roma
Italy	Struttura Complessa di Oncologia Medica A	Roma
Italy	UO di Oncologia ed Ematologia, Istituto Clinico Humanitas	Rozzano (MI)
Japan	Akita University Hospital	Akita
Japan	Tokyo Women's Medical University Medical Center East, Department of Urology	Arakawa-ku	Tokyo
Japan	Chiba Cancer Center	Chiba
Japan	National Cancer Center Hospital	Chuo-Ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	Hamamatsu University School of Medicine	Hamamatsu-City	Shizuoka
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kinki University Hospital	Osakasayama	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University School of Medicine	Sapporo-shi	Hokkaido
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Tokushima University	Tokushima
Japan	University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology	Tsukuba	Ibaraki
Japan	Yamaguchi University Hospital	Ube-shi	Yamaguchi
Japan	Yamagata University Hospital	Yamagata
Korea, Republic of	Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology	Busan
Korea, Republic of	National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer	Goyang-si	Gyeonggi-do
Korea, Republic of	Catholic University of Korea, Seoul St. Mary's Hospital, Department of Oncology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Poland	Wojewodzkie Centrum Onkologii	Gdansk
Poland	Centrum Medyczne HCP	Poznan	Wielkopolska
Poland	Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego	Poznan
Poland	Pracownia Tomografii Komputerowej	Poznan
Poland	Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie	Poznan	Wielkopolska
Poland	Klinika Onkologii, Wojskowy Instytut Medyczny	Warszawa
Poland	Klinika Urologii i Onkologii Urologicznej	Wroclaw
Russian Federation	Cancer Research Center named after N.N. Blokhin, Biotherapy Department	Moscow
Russian Federation	Cancer Research Center named after N.N.Blokhin, Chemotherapy Department	Moscow
Russian Federation	Moscow Research Institute of Oncology P.A. Herzen	Moscow
Russian Federation	Russian Research Center of Roentgenology and Radiology	Moscow
Russian Federation	The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation	Moscow
Russian Federation	Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia	Obninsk	Kaluga Region
Russian Federation	City Clinical Oncology Dispensary	St. Petersburg
Singapore	National Cancer Centre Singapore	Singapore
Slovakia	Narodny Onkologicky ustav	Bratislava
Slovakia	Onkologicky Ustav sv. Alzbety	Bratislava
Slovakia	Nemocnica s poliklinikou Zilina	Zilina
Spain	Hospital Vall D¿Hebron	Barcelona
Spain	Institut Catala D'Oncologia L'Hospitalet	L'hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital Clinico Universitario Virgen de La Victoria	Malaga
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Universitetssjukhuset, Onkologiska kliniken	Linkoping
Sweden	Norrlands Universitetssjukhus, Onkologkliniken	Umea
Sweden	Onkologkliniken	Vaxjo
Taiwan	Chang Gung Medical Foundation-Kaohsiung Branch	Kaohsiung Hsien
Taiwan	Taichung Veterans General Hospital, Department of Surgery	Taichung
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
United Kingdom	Clatterbridge Centre for Oncology NHS Foundation Trust	Bebington, Wirral
United Kingdom	University of Birmingham, CRUK Institute for Cancer Studies	Birmingham
United Kingdom	Royal Bournemouth & Poole Hospitals	Bournemouth
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Addenbrooke`s Hospital	Cambridge
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Department of Medical Oncology, St. Bartholomew's Hospital	London
United Kingdom	Royal Marsden Hospital	London	England
United Kingdom	Mount Vernon Cancer Centre	Northwood	Middlesex
United Kingdom	University Department of Medical Oncology/Oxford Cancer Centre	Oxford
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	Surrey
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Virginia Cancer Specialists, PC	Arlington	Virginia
United States	Peachtree Hematology-Oncology Consultants, P.C.	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of Colorado Denver: Division of Medical Oncology	Aurora	Colorado
United States	Texas Oncolgoy - Austin North	Austin	Texas
United States	Texas Oncology - Austin Central	Austin	Texas
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	Texas Oncology - Austin Northwest	Austin	Texas
United States	Texas Oncology - Central Midtown	Austin	Texas
United States	Texas Oncology - South Austin	Austin	Texas
United States	Texas Oncology, P.A.	Bedford	Texas
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Florida Cancer Specialists	Bonita Springs	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Florida Cancer Specialists	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	East Valley Hematology and Oncology Medical Group	Burbank	California
United States	Maurice Berkowtiz, MD	Burbank	California
United States	Florida Cancer Specialists	Cape Coral	Florida
United States	Florida Cancer Specialists	Cape Coral	Florida
United States	Cental Indiana Cancer Centers	Carmel	Indiana
United States	Raleigh Hematology Oncology Associates, DBA	Cary	North Carolina
United States	Texas Oncology - Cedar Park	Cedar Park	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Chattanooga Oncology and Hematology Associates, PC	Chattanooga	Tennessee
United States	Chattanooga Oncology Hematology Associates P.C.	Chattanooga	Tennessee
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Rocky Mountain Cancer Centers	Colorado Springs	Colorado
United States	Missouri Cancer Associates	Columbia	Missouri
United States	James Care in Kenny	Columbus	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute	Columbus	Ohio
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	University of Miami Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Rocky Mountain Cancer Centers, LLP	Denver	Colorado
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Agajanian Institute of Oncology and Hematology	Downey	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Investigational Chemotherapy Services	Durham	North Carolina
United States	Cancer Centers of the Carolinas	Easley	South Carolina
United States	Albermarie Hospitals	Elizabeth City	North Carolina
United States	Virginia Oncology Associates	Elizabeth City	North Carolina
United States	Florida Cancer Specialists	Englewood	Florida
United States	Oncology Associates of Oregon, P.C.	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Weisberg Cancer Treatment Center	Farmington Hills	Michigan
United States	Central Indiana Cancer Centers	Fishers	Indiana
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Investigation Products Center (IPC)	Fort Worth	Texas
United States	Investigational Products Center (IPC)	Fort Worth	Texas
United States	US Oncology Research and Clinical Pharmacy	Fort Worth	Texas
United States	Tennessee Oncology, PLLC	Franklin	Tennessee
United States	Vanderbilt-Ingram Cancer Center-Cool Springs	Franklin	Tennessee
United States	Mountain States Tumor Institute	Fruitland	Idaho
United States	Virginia Cancer Specialists, PC	Gainesville	Virginia
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	Los Angeles Hematology/Oncology Medical Group	Glendale	California
United States	Cental Indiana Cancer Centers	Greenfield	Indiana
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Hematology and Oncology Associates of SC, LLC - Eastside Medical Center	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	The Cancer Center at Hackensack University Medical Center - The Hillcrest Building	Hackensack	New Jersey
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Tennessee Oncology, PLLC	Hermitage	Tennessee
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Chattanooga Oncology & Hematology Associates	Hixson	Tennessee
United States	Genitourinary Cancer Center	Houston	Texas
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
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	Nevada Cancer Institute	Las Vegas	Nevada
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	Virginia Cancer Specialists, PC	Leesburg	Virginia
United States	Rocky Mountain Cancer Centers	Littleton	Colorado
United States	Rocky Mountain Cancer Centers	Lone Tree	Colorado
United States	Rocky Mountain Cancer Centers	Longmont	Colorado
United States	Kenmar Research Institute	Los Angeles	California
United States	LAC-USC Medical Center	Los Angeles	California
United States	Los Angeles Hematology/Oncology Medical Group	Los Angeles	California
United States	Metropolitan Hematology/Oncology Medical Group	Los Angeles	California
United States	Ronald Regan UCLA Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	USC Norris Cancer Hospital and Clinics	Los Angeles	California
United States	Monarch	Mayfield Heights	Ohio
United States	Loyola University Chicago Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	Lake University - Ireland Cancer Center (LUICC)	Mentor	Ohio
United States	Mountain States Tumor Institute	Meridian	Idaho
United States	University of Miami Hospital and Clinics	Miami	Florida
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Agajanian Institute of Oncology and Hematology	Montebello	California
United States	Tennessee Oncology, PLLC	Murfreesboro	Tennessee
United States	Mountain States Tumor Institute	Nampa	Idaho
United States	Florida Cancer Specialists	Naples	Florida
United States	Florida Cancer Specialists	Naples	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.	Oneida	New York
United States	UHHS - Chagrin Highlands	Orange Village	Ohio
United States	M.D. Anderson Cancer Center Orlando	Orlando	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.	Oswego	New York
United States	Rocky Mountain Cancer Centers	Parker	Colorado
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Florida Cancer Specialists	Port Charlotte	Florida
United States	Raleigh Hematology Oncology Associates, P.C.	Raleigh	North Carolina
United States	Chattanooga Oncology and Hematology Associates, PC	Ringgold	Georgia
United States	Texas Oncology - Round Rock	Round Rock	Texas
United States	Texas Oncology - Seton Williamson	Round Rock	Texas
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	St. John's Mercy, David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Florida Cancer Specialists	Sarasota	Florida
United States	Florida Cancer Specialists	Sarasota	Florida
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center, Section of Hematology/Oncology	Seattle	Washington
United States	Cancer Centers of the Carolinas, Seneca	Seneca	South Carolina
United States	Tennessee Oncology, PLLC	Smyrna	Tennessee
United States	Cancer Centers of the Carolinas	Spartanburg	South Carolina
United States	Willamette Valley Cancer Institute and Research Center	Springfield	Oregon
United States	Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc	Syracuse	New York
United States	Suny Upstate Medical University	Syracuse	New York
United States	Rocky Mountain Cancer Centers	Thornton	Colorado
United States	Mountain States Tumor Institute	Twin Falls	Idaho
United States	Texas Oncology, P.A.	Tyler	Texas
United States	Florida Cancer Specialists	Venice	Florida
United States	Florida Cancer Specialists	Venice	Florida
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	Georgetown University Hospital, Lombardi Cancer Center	Washington	District of Columbia
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	St. John's Mercy Medical Center	Washington	Missouri
United States	Deke Slayton Cancer Center	Webster	Texas
United States	Texas Oncology - Clear Lake	Webster	Texas
United States	Brian LeBerthon, MD, A Medical Corporation	West Covina	California
United States	UHHS - Westlake	Westlake	Ohio
United States	Agajanian Institute of Oncology and Hematology	Whittier	California
United States	Virginia Cancer Specialists, PC	Woodbridge	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Canada,  China,  France,  Germany,  Greece,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Overall Survival (OS)	OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Objective Response Rate (ORR)	ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Duration of Response (DR)	DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Percentage of Participants With Adverse Events (AEs) by Severity	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non -serious AEs.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology	Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry	Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis	Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.	From initiation of treatment up to follow-up period (up to 3 years)
Secondary	Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score	FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary	Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score	FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary	Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Secondary	Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.	Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)

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