A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
NCT ID: NCT01865747
Last Updated: 2021-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
658 participants
INTERVENTIONAL
2013-06-30
2021-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily.
Cabozantinib tablets
Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily.
Everolimus (Afinitor) tablets
Interventions
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Cabozantinib tablets
Everolimus (Afinitor) tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Measurable disease as determined by the investigator.
3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
5. Adequate organ and marrow function.
6. 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.
7. Female subjects of childbearing potential must not be pregnant at screening.
Exclusion Criteria
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
4. 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.
5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
7. Chronic treatment with corticosteroids or other immunosuppressive agents.
8. Serious illness other than cancer.
9. 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.
10. Pregnant or lactating females.
11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Anchorage, Alaska, United States
Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Vallejo, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Westwood, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Albany, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Yakima, Washington, United States
La Plata, Buenos Aires, Argentina
Mar del Plata, , Argentina
Concord, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
Wahroonga, New South Wales, Australia
Westmead, New South Wales, Australia
Milton, Queensland, Australia
Wooloongabba, Queensland, Australia
Adelaide, South Australia, Australia
Hobart, Tasmania, Australia
Bentleight East, Victoria, Australia
Box Hill, Victoria, Australia
Wodonga, Victoria, Australia
Linz, Upper Austria, Austria
Vienna, , Austria
Vienna, , Austria
Bonheiden, Antwerpen, Belgium
Brasschaat, Antwerpen, Belgium
Brussels, Brussels Capital, Belgium
Leuven, Vlaams Brabant, Belgium
Roeselare, West-Vlaanderen, Belgium
Antwerp, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnepeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Santiago, , Chile
Olomouc, Olomoucký kraj, Czechia
Brno, , Czechia
Prague, , Czechia
Herlev, Capital Region, Denmark
Aarhus, Central Jutland, Denmark
Odense, Region Syddanmark, Denmark
Turku, Länsi-Suomen Lääni, Finland
Helsinki, , Finland
Caen, Calvados, France
Besançon, Doubs, France
Bordeaux, Gironde, France
Toulouse, Haute-Garonne, France
Rennes, Ille-et-Vilaine, France
Nantes, Loire-Atlantique, France
Lyon, Rhône, France
Le Mans, Sarthe, France
Villejuif, Val-de-Marne, France
Marseille, , France
Paris, , France
Freiburg im Breisgau, Baden Wuttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Ulm, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Aachen, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Erfurt, Thuringia, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Dresden, , Germany
Frankfurt am Main, , Germany
Gütersloh, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Munich, , Germany
München, , Germany
Budapest, , Hungary
Szolnok, , Hungary
Dublin, , Ireland
Dublin, , Ireland
Bari, Apulia, Italy
Meldola, Emilia-Romagna, Italy
Modena, Emilia-Romagna, Italy
Ravenna, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Cremona, Lombardy, Italy
Arezzo, Tuscany, Italy
Terni, Umbria, Italy
Maastricht, Limburg, Netherlands
Amsterdam, North Holland, Netherlands
Leiden, South Holland, Netherlands
Rotterdam, South Holland, Netherlands
Poznan, Greater Poland Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Gdansk, Pomeranian Voivodeship, Poland
Warsaw, , Poland
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Moscow, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Prešov, , Slovakia
Žilina, , Slovakia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Badalona, Catalonia, Spain
Barcelona, Catalonia, Spain
L'Hospitalet de Llobregat, Catalonia, Spain
Pamplona, Navarre, Spain
Oviedo, Principality of Asturias, Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Lund, Skåne County, Sweden
Stockholm, Södermanland County, Sweden
Umeå, , Sweden
Taichung, , Taiwan
Taipei, , Taiwan
Ankara, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Birmingham, England, United Kingdom
Derby, England, United Kingdom
Guildford, England, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
Manchester, England, United Kingdom
Metropolitan Borough of Wirral, England, United Kingdom
Northwood, England, United Kingdom
Aberdeen, Scotland, United Kingdom
Edinburgh, Scotland, United Kingdom
Glasgow, Scotland, United Kingdom
Countries
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References
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Gong AJ, Ruchalski K, Kim HJ, Douek M, Gutierrez A, Patel M, Sai V, Coy H, Villegas B, Raman S, Goldin J. RECIST 1.1 Target Lesion Categorical Response in Metastatic Renal Cell Carcinoma: A Comparison of Conventional versus Volumetric Assessment. Radiol Imaging Cancer. 2023 Sep;5(5):e220166. doi: 10.1148/rycan.220166.
Denize T, Farah S, Cimadamore A, Flaifel A, Walton E, Sticco-Ivins MA, Labaki C, Braun DA, Sun M, Wang E, Xie W, Choueiri TK, Signoretti S. Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial. Clin Cancer Res. 2022 Feb 15;28(4):748-755. doi: 10.1158/1078-0432.CCR-21-3088.
Powles T, Choueiri TK, Motzer RJ, Jonasch E, Pal S, Tannir NM, Signoretti S, Kaldate R, Scheffold C, Wang E, Aftab DT, Escudier B, George DJ. Outcomes based on plasma biomarkers in METEOR, a randomized phase 3 trial of cabozantinib vs everolimus in advanced renal cell carcinoma. BMC Cancer. 2021 Aug 7;21(1):904. doi: 10.1186/s12885-021-08630-w.
Donskov F, Motzer RJ, Voog E, Hovey E, Grullich C, Nott LM, Cuff K, Gil T, Jensen NV, Chevreau C, Negrier S, Depenbusch R, Bergmann L, Cornelio I, Champsaur A, Escudier B, Pal S, Powles T, Choueiri TK. Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma. Eur J Cancer. 2020 Feb;126:1-10. doi: 10.1016/j.ejca.2019.10.032. Epub 2019 Dec 27.
Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.
Cella D, Escudier B, Tannir NM, Powles T, Donskov F, Peltola K, Schmidinger M, Heng DYC, Mainwaring PN, Hammers HJ, Lee JL, Roth BJ, Marteau F, Williams P, Baer J, Mangeshkar M, Scheffold C, Hutson TE, Pal S, Motzer RJ, Choueiri TK. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. J Clin Oncol. 2018 Mar 10;36(8):757-764. doi: 10.1200/JCO.2017.75.2170. Epub 2018 Jan 29.
Escudier B, Powles T, Motzer RJ, Olencki T, Aren Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.
Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.
Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Geczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.
Other Identifiers
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XL184-308
Identifier Type: -
Identifier Source: org_study_id
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