Von Hippel-Lindau Disease Clinical Trial

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma


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.

View Eligibility Criteria

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.

Study is for people with:

Von Hippel-Lindau Disease


Phase 3

Estimated Enrollment:


Study ID:


Recruitment Status:




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There are 193 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Von Hippel-Lindau Disease


Phase 3

Estimated Enrollment:


Study ID:


Recruitment Status:




How clear is this clinincal trial information?


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