Spots Global Cancer Trial Database for A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
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Trial Identification
Brief Title: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
Official Title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
Study ID: NCT02627963
Conditions
Study Description
Brief Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor \[programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor\] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Of UA Cancer Center(UACC)/DH-SJHMC, Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HAL, Phoenix, Arizona, United States
Arizona Oncology - Phoenix - Deer Valley Women's Center Loca, Phoenix, Arizona, United States
Arizona Oncology - Scottsdale, Scottsdale, Arizona, United States
City of Hope Comprehensive Breast Cancer Center, Duarte, California, United States
Long Beach Memorial Medical Center, Fountain Valley, California, United States
Marin Cancer Care, Greenbrae, California, United States
UCLA, Los Angeles, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Loyola University Medical Center, Maywood, Illinois, United States
Investigative Clinical Research of Indiana, Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Midwest Cancer Center, Omaha, Nebraska, United States
Urology Cancer Center, PC, Omaha, Nebraska, United States
Comprehensive Cancer Center Of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Center Of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States
Hackensack University Medical Center - John Theurer Cancer, Hackensack, New Jersey, United States
New York Oncology Hematology, P.C., Albany, New York, United States
New York Oncology Hematology, PC, Albany, New York, United States
Montefiore Medical Center, Bronx, New York, United States
New York Oncology Hematology, P.C., Clifton Park, New York, United States
New York Presbyterian Hospital, New York, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Wake Forest University Baptist Medical Center (WFUBMC), Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio Cancer Specialists, Mansfield, Ohio, United States
North Coast Cancer Care, Inc, Sandusky, Ohio, United States
Wooster Specialty and Surgery Center, Wooster, Ohio, United States
St. Luke University Health Network, Easton, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology-Central Austin Cancer Center, Austin, Texas, United States
Texas Oncology - South Austin Cancer Center, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Fort Worth 12th Ave, Fort Worth, Texas, United States
Texas Oncology SW Fort Worth Cancer Center, Fort Worth, Texas, United States
Arizona Oncology Associates, PC - HAL, Fort Worth, Texas, United States
Comprehensive Cancer Centers of Nevada (CCCN), Fort Worth, Texas, United States
Comprehensive Cancer Centers of Nevada, Fort Worth, Texas, United States
Nebraska Cancer Specialists (NCS) - Midwest Cancer Center, Fort Worth, Texas, United States
Texas Oncology - El Paso Cancer Treatment Center, Fort Worth, Texas, United States
Texas Oncology-El Paso Cancer Treatment Center, Fort Worth, Texas, United States
Texas Oncology-Garland, Garland, Texas, United States
Baylor College of Medicine - Baylor Clinic, Houston, Texas, United States
Texas Oncology - Longview Cancer Center, Longview, Texas, United States
Texas Oncology, P.A., Plano, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
UZ Antwerpen, Edegem, Antwerpen, Belgium
Institut Jules Bordet, Bruxelles, Brussels Capital Region, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi, Hainaut, Belgium
CHU Ambroise Paré, Mons, Hainaut, Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, Limburg, Belgium
CHU Dinant Godinne UCL Namur, Yvoir, Namur, Belgium
UZ Gent, Gent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan, Brugge, West-Vlaanderen, Belgium
British Columbia Cancer Agency (BCCA), Vancouver, British Columbia, Canada
Dr. Leon Richard Oncology Centre, Moncton, New Brunswick, Canada
London Health Sciences Center, London, Ontario, Canada
Sunnybrook, Toronto, Ontario, Canada
Masarykuv onkologicky ustav, Brno, Brno-město, Czechia
FN Hradec Kralove, Hradec Kralove, Královéhradecký Kraj, Czechia
Fakultni nemocnice Olomouc, Olomouc, Olomoucký Kraj, Czechia
Fakultni nemocnice u sv. Anny v Brne, Brno, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
Herlev Hospital, Herlev, Capital, Denmark
Aarhus Universitetshospital, Aarhus C, Central Jutland, Denmark
Odense Universitetshospital, Odense, South Denmark, Denmark
Hopital Saint-André, Bordeaux Cedex, Gironde, France
CHRU de Tours - Hopital Bretonneau TOURS, Tours CEDEX 1, Indre-et-Loire, France
Institut de Cancerologie de la Loire, Saint-Priest-en-Jarez, Loire, France
Institut de Cancérologie de l'Ouest Site Paul Papin, Angers, Maine-et-Loire, France
Institut de cancérologie de Lorraine, Vandoeuvre Les Nancy, Meurthe-et-Moselle, France
centre Oscar Lambret, Lille, Nord-Pas-de-Calais, France
Clinique Victor Hugo, Le Mans, Pays-de-la-Loire, France
Institut Paoli-Calmettes, Marseille Cedex 09, , France
Chu De Poitiers, Poitiers, , France
ICO, Saint Herblain CEDEX, , France
Institut Gustave Roussy, Villejuif, , France
Universitätsklinikum Freiburg, Freiburg, Baden-Württemberg, Germany
Univesitaetsklinik Heidelberg, Heidelberg, Baden-Württemberg, Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden, Bayern, Germany
Johann Wolfgang Goethe Universität, Frankfurt am Main, Hessen, Germany
Evangelisches Krankenhaus Bielefeld, Bielefeld, Nordrhein-Westfalen, Germany
SZB Study Center University Hospital Bonn, Bonn, Nordrhein-Westfalen, Germany
Uniklinik Köln Klinik und Poliklinik für Urologie, Köln, Nordrhein-Westfalen, Germany
Universitätsklinikum des Saarlandes, Homburg, Saarland, Germany
Universitätsklinikum Carl Gustav Carus, Dresden, Sachsen, Germany
Jena University Hospital, Jena, Thüringen, Germany
Universitätsklinikum Aachen, Aachen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Universität Tübingen, Tübingen, , Germany
Pécsi Tudományegyetem Klinikai Központ, Pécs, Baranya, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc, Borsod-Abaúj-Zemplén, Hungary
Békés Megyei Pándy Kálmán Kórház, Gyula, Békés, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo, Szeged, Csongrád, Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, Hajdú-Bihar, Hungary
Szent Margit Kórház, Budapest, , Hungary
Magyar Honvédség Egészségügyi Központ, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Semmelweis Egyetem, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Egyesített Szent István és Szent László Kórház-Rendelőintéze, Budapest, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Markusovszky Egyetemi Oktatókórház, Szombathely, , Hungary
Zala Megyei Korhaz, Zalaegerszeg, , Hungary
Casa Sollievo della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy
Irccs Irst, Meldola, Forli, Italy
Istituto Clinico Humanitas Rozzano, IRCCS, Rozzano, Milano, Italy
Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST, Poggibonsi, Siena, Italy
Istituto di Candiolo, IRCCS, Candiolo, Torino, Italy
Ospedale S.Donato, AUSL 8 di Arezzo, Arezzo, , Italy
Centro di Riferimento Oncologico IRCCS, Aviano, , Italy
AO Spedali Civili di Brescia, PO Spedali Civili, Brescia, , Italy
P.O. Ss. Annunziata, Chieti, , Italy
ASST-Istituti Ospitalieri di Cremona, AO di Cremona, Cremona, , Italy
AOU Careggi, Firenze, , Italy
IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca, Genova, , Italy
Ospedale Vito Fazzi, ASL Lecce, Lecce, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Ieo, Irccs, Milano, , Italy
AOU Policlinico di Modena, Modena, , Italy
IRCCS Fondazione "Giovanni Pascale", Napoli, , Italy
Istituto Oncologico Veneto IOV-IRCCS, Padova, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
PU Campus Bio-medico di Roma, Roma, , Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS, Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
Azienda Ospedaliera S. Maria di Terni, Terni, , Italy
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina, Otwock, Mazowieckie, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie, Warszawa, Mazowieckie, Poland
MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny, Warszawa, Mazowieckie, Poland
Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny, Brzozow, , Poland
COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii, Gdansk, , Poland
NZOZ Vesalius Sp. z o.o., Krakow, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego, Wroclaw, , Poland
H.G.U. de Elche, Elche, Alicante, Spain
H.U.Son Espases, Palma, Baleares, Spain
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Institut Catalá d´Oncología (I.C.O.), L'Hospitalet De Llobregat, Barcelona, Spain
C.S. Parc Taulí, Sabadell, Barcelona, Spain
H.U.F. Alcorcón, Alcorcón, Madrid, Spain
H.U.P Hierro-Majadahonda, Majadahonda, Madrid, Spain
C.H. de Navarra, Pamplona, Navarra, Spain
H.del Mar, Barcelona, , Spain
H.Sta.Creu i St.Pau, Barcelona, , Spain
H.U.Vall d'Hebrón, Barcelona, , Spain
H. Clinic de Barcelona, Barcelona, , Spain
H.U. Reina Sofía, Córdoba, , Spain
ICO-H.U.Dr.J.Trueta, Girona, , Spain
C.H. de Jaén, Jaén, , Spain
H.G.U. G. Marañón, Madrid, , Spain
H.U. Infanta Leonor, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
H.C. S.Carlos, Madrid, , Spain
H.U. F. Jiménez Díaz, Madrid, , Spain
H.U. 12 de Octubre, Madrid, , Spain
H.U. La Paz, Madrid, , Spain
H. Madrid Norte Sanchinarro, Madrid, , Spain
H.U. Virgen de la Victoria, Málaga, , Spain
H.U.V. Macarena, Sevilla, , Spain
F.I. Valenciano de Oncología, Valencia, , Spain
H.U.P.La Fe, Valencia, , Spain
H.U. Miguel Servet, Zaragoza, , Spain
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
Beatson West Of Scotland Cancer Centre, Glasgow, Glasgow City, United Kingdom
Cheltenham General Hospital, Cheltenham, Gloucestershire, United Kingdom
Southampton University Hospitals Nhs Trust, Southampton, Hampshire, United Kingdom
East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, United Kingdom
Royal Stroke Center, Stoke-on-Trent, Staffordshire, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
St James's University Hospital / Leeds Teaching Hospitals, Leeds, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Charing Cross Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Mount Vernon Cancer Care, Middlesex, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Churchill Hospital [Oncology], Oxford, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
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