Von Hippel-Lindau Disease Clinical Trial
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Summary
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.
Eligibility Criteria
Select Inclusion Criteria:
Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
Measurable disease as determined by the investigator.
Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Adequate organ and marrow function.
Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
Female subjects of childbearing potential must not be pregnant at screening.
Select Exclusion Criteria:
Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
Chronic treatment with corticosteroids or other immunosuppressive agents.
Serious illness other than cancer.
Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
Pregnant or lactating females.
Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
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There are 193 Locations for this study
Birmingham Alabama, , United States
Anchorage Alaska, 99503, United States
Gilbert Arizona, 85234, United States
Scottsdale Arizona, 85259, United States
Tucson Arizona, 85724, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Vallejo California, 94589, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80218, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Miami Florida, 33136, United States
Miami Florida, 33176, United States
Orlando Florida, 06520, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Iowa City Iowa, 52242, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89148, United States
Albany New York, 12206, United States
New York New York, 10065, United States
Durham North Carolina, 22710, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29425, United States
Knoxville Tennessee, 37920, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78731, United States
Bedford Texas, 76022, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Vancouver Washington, 98684, United States
Yakima Washington, 98902, United States
La Plata Buenos Aires, B1900, Argentina
Mar Del Plata , B7600, Argentina
Concord New South Wales, 2139, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Port Macquarie New South Wales, , Australia
Randwick New South Wales, 2031, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
Milton Queensland, 4064, Australia
Wooloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Hobart Tasmania, 7000, Australia
Bentleight East Victoria, 3165, Australia
Box Hill Victoria, 3128, Australia
Wodonga Victoria, 3690, Australia
Linz Oberösterreich, 4010, Austria
Wien , 1090, Austria
Wien , 1100, Austria
Bonheiden Antwerpen, 2820, Belgium
Brasschaat Antwerpen, 2930, Belgium
Bruxelles Brussels, 1000, Belgium
Leuven Vlaams Brabant, 3000, Belgium
Roeselare West-Vlaanderen, 8800, Belgium
Antwerpen , 2020, Belgium
Liege , 4000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Winnepeg Manitoba, R3A 1, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L 4, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Santiago , , Chile
Olomouc Olomoucký Kraj, 775 2, Czechia
Brno , 656 9, Czechia
Prague , 128 0, Czechia
Herlev Hovedstaden, DK-27, Denmark
Aarhus Midtjylland, DK-80, Denmark
Odense Syddanmark, DK-50, Denmark
Turku Länsi-Suomen Lääni, FI-20, Finland
Helsinki , 290, Finland
Caen Calvados, 14076, France
Besancon Doubs, 25030, France
Bordeaux Gironde, 33075, France
Toulouse Haute-Garonne, 31052, France
Rennes Ille-et-Vilaine, 35042, France
Nantes Loire-Atlantique, 44805, France
Lyon Rhône, 96008, France
Le Mans Sarthe, 72000, France
Villejuif Val-de-Marne, 94805, France
Marseille , 13273, France
Paris , 75908, France
Freiburg Baden Wuttemberg, 79106, Germany
Tubingen Baden-Württemberg, 72076, Germany
Ulm Baden-Württemberg, 89075, Germany
Erlangen Bayern, 91054, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Essen Nordrhein-Westfalen, 45122, Germany
Mainz Rheinland-Pfalz, 55131, Germany
Jena Thuringen, 99089, Germany
Erfurt Thüringen, 99089, Germany
Berlin , 12200, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60590, Germany
Guetersloh , 33332, Germany
Hamburg , 20246, Germany
Hannover , 30605, Germany
Heidelberg , 69120, Germany
Munchen , 81675, Germany
Munich , 81377, Germany
Budapest , 1122, Hungary
Szolnok , 5004, Hungary
Dublin , 24, Ireland
Dublin , 7, Ireland
Meldola Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41124, Italy
Ravenna Emilia-Romagna, 48100, Italy
Rome Lazio, 00128, Italy
Rome Lazio, 00152, Italy
Genova Liguria, 16132, Italy
Cremona Lombardia, Lomba, Italy
Bari Puglia, 70124, Italy
Arezzo Toscana, 52100, Italy
Terni Umbria, 05100, Italy
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , , Korea, Republic of
Maastricht Limburg, 6229 , Netherlands
Amsterdam Noord-Holland, 1066 , Netherlands
Leiden Zuid-Holland, 2333 , Netherlands
Rotterdam Zuid-Holland, 3045 , Netherlands
Bialystok Podlaskie, 15-02, Poland
Gdansk Pomorskie, 80-21, Poland
Poznan Wielkopolskie, 60-56, Poland
Warsaw , 04-90, Poland
Lisbon , 1500-, Portugal
Lisbon , 1649-, Portugal
Porto , 200-0, Portugal
Moscow , 11547, Russian Federation
Omsk , 64401, Russian Federation
St. Petersburg , 19624, Russian Federation
Yaroslavl , 15004, Russian Federation
Presov , 08001, Slovakia
Zilina , 01207, Slovakia
Oviedo Asturias, 33006, Spain
Barcelona Cataluna, 08025, Spain
Badalona Cataluña, 08003, Spain
L'Hospitalet de Llobregat Cataluña, 08907, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28922, Spain
Málaga , Mála, Spain
Santiago de Compostela , 15706, Spain
Seville , 28050, Spain
Valencia , 46010, Spain
Lund Skane Lan, SE-22, Sweden
Stockholm Sodermanlands Lan, , Sweden
Umea , , Sweden
Taichung , , Taiwan
Taipei , , Taiwan
Ankara , 6500, Turkey
Gaziantep , 27100, Turkey
Istanbul , 34365, Turkey
Izmir , 35100, Turkey
Birmingham England, B15 2, United Kingdom
Derby England, DE22 , United Kingdom
Guildford England, GU2 7, United Kingdom
London England, EC1A , United Kingdom
London England, SE1 9, United Kingdom
London England, , United Kingdom
Manchester England, M20 4, United Kingdom
Northwood England, HA6 2, United Kingdom
Wirral England, CH63 , United Kingdom
Aberdeen Scotland, AB25 , United Kingdom
Edinburgh Scotland, EH4 2, United Kingdom
Glasgow Scotland, , United Kingdom
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