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

Last updated: April 1, 2021
Sponsor: Exelixis
Overall Status: Completed

Phase

3

Condition

Carcinoma

Cancer/tumors

Renal Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT01865747
XL184-308
  • Ages > 18
  • All Genders

Study 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

Inclusion

Select Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell cancer with aclear-cell component.
  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 clinicallynonsignificant 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 acceptedmethods of contraception during the course of the study and for 4 months after thelast dose of study treatment.
  7. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion

Select Exclusion Criteria:

  1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKTinhibitor (eg, temsirolimus), or cabozantinib.
  2. Receipt of any type of small molecule kinase inhibitor (including investigationalkinase 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 radiationtherapy within 4 weeks before randomization. Systemic treatment with radionuclideswithin 6 weeks before randomization. Subjects with clinically relevant ongoingcomplications from prior radiation therapy are not eligible.
  5. Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy and/or surgery and stable for at least 3 months before randomization.
  6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or plateletinhibitors.
  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 majorsurgery must have occurred 1 month before randomization and from minor surgery atleast 10 days before randomization.
  10. Pregnant or lactating females.
  11. Diagnosis of another malignancy within 2 years before randomization, except forsuperficial skin cancers, or localized, low grade tumors.

Study Design

Total Participants: 658
Study Start date:
June 01, 2013
Estimated Completion Date:
January 15, 2021

Connect with a study center

  • La Plata, Buenos Aires B1900BAJ
    Argentina

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    Buenos Aires,
    Argentina

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  • Mar Del Plata, B7600LTO
    Argentina

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  • Concord, New South Wales 2139
    Australia

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  • Darlinghurst, New South Wales 2010
    Australia

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  • Kogarah, New South Wales 2217
    Australia

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  • Port Macquarie, New South Wales
    Australia

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  • Randwick, New South Wales 2031
    Australia

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    Sydney, New South Wales
    Australia

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  • Wahroonga, New South Wales 2076
    Australia

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  • Westmead, New South Wales 2145
    Australia

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    Brisbane, Queensland
    Australia

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  • Milton, Queensland 4064
    Australia

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  • Wooloongabba, Queensland 4102
    Australia

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  • Adelaide, South Australia 5000
    Australia

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  • Hobart, Tasmania 7000
    Australia

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  • Bentleight East, Victoria 3165
    Australia

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  • Box Hill, Victoria 3128
    Australia

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    Melbourne, Victoria
    Australia

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  • Wodonga, Victoria 3690
    Australia

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    Ipswich,
    Australia

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  • Linz, Oberösterreich 4010
    Austria

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    Salzburg,
    Austria

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    Vienna,
    Austria

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  • Wien, 1090
    Austria

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  • Bonheiden, Antwerpen 2820
    Belgium

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  • Brasschaat, Antwerpen 2930
    Belgium

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  • Bruxelles, Brussels 1000
    Belgium

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  • Leuven, Vlaams Brabant 3000
    Belgium

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  • Roeselare, West-Vlaanderen 8800
    Belgium

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    Antwerp,
    Belgium

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  • Antwerpen, 2020
    Belgium

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    Brussels,
    Belgium

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  • Liege, 4000
    Belgium

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    Porto Alegre,
    Brazil

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    Rio de Janeiro,
    Brazil

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    Sao Paulo,
    Brazil

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    São Paulo, 01246 000
    Brazil

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  • Calgary, Alberta T2N 4N2
    Canada

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  • Edmonton, Alberta T6G 1Z2
    Canada

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  • Vancouver, British Columbia V5Z 4E6
    Canada

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  • Winnepeg, Manitoba R3A 1R9
    Canada

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  • Halifax, Nova Scotia B3H 1V7
    Canada

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  • Hamilton, Ontario L8V 5C2
    Canada

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  • Kingston, Ontario K7L 5P9
    Canada

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  • London, Ontario N6A 4L6
    Canada

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  • Oshawa, Ontario L1G 2B9
    Canada

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  • Ottawa, Ontario K1H 8L6
    Canada

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  • Toronto, Ontario M5G 2N2
    Canada

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  • Montreal, Quebec H2L 4M1
    Canada

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  • Saskatoon, Saskatchewan S7N 4H4
    Canada

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  • Santiago,
    Chile

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  • Olomouc, Olomoucký Kraj 775 20
    Czechia

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  • Brno, 656 91
    Czechia

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  • Prague, 128 08
    Czechia

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  • Herlev, Hovedstaden DK-2730
    Denmark

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  • Aarhus, Midtjylland DK-8000
    Denmark

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  • Odense, Syddanmark DK-5000
    Denmark

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  • Turku, Länsi-Suomen Lääni FI-20520
    Finland

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  • Helsinki, 290
    Finland

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  • Caen, Calvados 14076
    France

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  • Besancon, Doubs 25030
    France

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  • Bordeaux, Gironde 33075
    France

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  • Toulouse, Haute-Garonne 31052
    France

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  • Rennes, Ille-et-Vilaine 35042
    France

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  • Nantes, Loire-Atlantique 44805
    France

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  • Lyon, Rhône 96008
    France

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  • Le Mans, Sarthe 72000
    France

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  • Villejuif, Val-de-Marne 94805
    France

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  • Marseille, 13273
    France

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  • Paris, 75908
    France

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    Reinnes,
    France

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  • Freiburg, Baden Wuttemberg 79106
    Germany

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  • Tubingen, Baden-Württemberg 72076
    Germany

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  • Ulm, Baden-Württemberg 89075
    Germany

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  • Erlangen, Bayern 91054
    Germany

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  • Aachen, Nordrhein-Westfalen 52074
    Germany

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  • Essen, Nordrhein-Westfalen 45122
    Germany

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  • Mainz, Rheinland-Pfalz 55131
    Germany

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  • Jena, Thuringen 99089
    Germany

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  • Erfurt, Thüringen 99089
    Germany

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  • Berlin, 12200
    Germany

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  • Dresden, 01307
    Germany

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    Frankfurt,
    Germany

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  • Frankfurt am Main, 60590
    Germany

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  • Guetersloh, 33332
    Germany

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  • Hamburg, 20246
    Germany

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  • Hannover, 30605
    Germany

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  • Heidelberg, 69120
    Germany

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  • Munchen, 81675
    Germany

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  • Munich, 81377
    Germany

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    Munster,
    Germany

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  • Budapest, 1122
    Hungary

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  • Szolnok, 5004
    Hungary

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  • Dublin, 24
    Ireland

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  • Meldola, Emilia-Romagna 47014
    Italy

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  • Modena, Emilia-Romagna 41124
    Italy

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  • Ravenna, Emilia-Romagna 48100
    Italy

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  • Rome, Lazio 00128
    Italy

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  • Genova, Liguria 16132
    Italy

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  • Cremona, Lombardia Lombardia
    Italy

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  • Bari, Puglia 70124
    Italy

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  • Arezzo, Toscana 52100
    Italy

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  • Terni, Umbria 05100
    Italy

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    Pavia,
    Italy

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    San Donato Milanese,
    Italy

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  • Seoul, 110-744
    Korea, Republic of

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  • Maastricht, Limburg 6229 HX
    Netherlands

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  • Amsterdam, Noord-Holland 1066 CX
    Netherlands

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  • Leiden, Zuid-Holland 2333 ZA
    Netherlands

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  • Rotterdam, Zuid-Holland 3045 PM
    Netherlands

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  • Bialystok, Podlaskie 15-027
    Poland

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  • Gdansk, Pomorskie 80-210
    Poland

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  • Poznan, Wielkopolskie 60-569
    Poland

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  • Warsaw, 04-909
    Poland

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  • Lisbon, 1500-650
    Portugal

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  • Porto, 200-072
    Portugal

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  • Moscow, 115478
    Russian Federation

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  • Omsk, 644013
    Russian Federation

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  • St. Petersburg, 196247
    Russian Federation

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  • Yaroslavl, 150040
    Russian Federation

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  • Presov, 08001
    Slovakia

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  • Zilina, 01207
    Slovakia

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  • Oviedo, Asturias 33006
    Spain

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  • Barcelona, Cataluna 08025
    Spain

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  • Badalona, Cataluña 08003
    Spain

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  • L'Hospitalet de Llobregat, Cataluña 08907
    Spain

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  • Pamplona, Navarra 31008
    Spain

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    Alcorcón,
    Spain

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  • Madrid, 28041
    Spain

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  • Málaga, Málaga
    Spain

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  • Santiago de Compostela, 15706
    Spain

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  • Seville, 28050
    Spain

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  • Valencia, 46010
    Spain

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  • Lund, Skane Lan SE-22185
    Sweden

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  • Stockholm, Sodermanlands Lan
    Sweden

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  • Umea,
    Sweden

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  • Taichung,
    Taiwan

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  • Taipei,
    Taiwan

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  • Ankara, 6500
    Turkey

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    Bornova,
    Turkey

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  • Gaziantep, 27100
    Turkey

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  • Istanbul, 34365
    Turkey

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  • Izmir, 35100
    Turkey

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  • Birmingham, England B15 2TH
    United Kingdom

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  • Derby, England DE22 3NE
    United Kingdom

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  • Guildford, England GU2 7XX
    United Kingdom

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  • London, England SE1 9ER
    United Kingdom

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  • Manchester, England M20 4BX
    United Kingdom

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  • Northwood, England HA6 2RN
    United Kingdom

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  • Wirral, England CH63 4JY
    United Kingdom

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  • Aberdeen, Scotland AB25 2ZN
    United Kingdom

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  • Edinburgh, Scotland EH4 2XU
    United Kingdom

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  • Glasgow, Scotland
    United Kingdom

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    Bristol,
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    Leeds,
    United Kingdom

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    Liverpool,
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    Middlesex,
    United Kingdom

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  • Birmingham, Alabama
    United States

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  • Anchorage, Alaska 99503
    United States

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  • Gilbert, Arizona 85234
    United States

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  • Scottsdale, Arizona 85259
    United States

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  • Tucson, Arizona 85724
    United States

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  • Duarte, California 91010
    United States

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  • La Jolla, California 92093
    United States

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  • Los Angeles, California 90095
    United States

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  • Vallejo, California 94589
    United States

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  • Aurora, Colorado 80045
    United States

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  • Denver, Colorado 80218
    United States

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  • New Haven, Connecticut 06520
    United States

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  • Washington, District of Columbia 20007
    United States

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    Washington, D.C., District of Columbia 20007
    United States

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  • Boca Raton, Florida 33486
    United States

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    Fort Myers, Florida
    United States

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  • Miami, Florida 33176
    United States

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  • Orlando, Florida 06520
    United States

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  • Tampa, Florida 33612
    United States

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  • Chicago, Illinois 60612
    United States

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  • Iowa City, Iowa 52242
    United States

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  • Westwood, Kansas 66205
    United States

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  • Baltimore, Maryland 21287
    United States

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  • Boston, Massachusetts 02215
    United States

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  • Ann Arbor, Michigan 48109
    United States

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  • Detroit, Michigan 48202
    United States

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  • Rochester, Minnesota 55905
    United States

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  • Saint Louis, Missouri 63110
    United States

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    St. Louis, Missouri
    United States

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    Henderson, Nevada
    United States

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  • Las Vegas, Nevada 89148
    United States

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  • Albany, New York 12206
    United States

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  • New York, New York 10065
    United States

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    Chapel Hill, North Carolina
    United States

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  • Durham, North Carolina 22710
    United States

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  • Cleveland, Ohio 44195
    United States

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    Clevland, Ohio 44195
    United States

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  • Columbus, Ohio 43210
    United States

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  • Portland, Oregon 97213
    United States

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  • Philadelphia, Pennsylvania 19111
    United States

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  • Pittsburgh, Pennsylvania 15232
    United States

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  • Charleston, South Carolina 29425
    United States

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  • Knoxville, Tennessee 37920
    United States

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  • Memphis, Tennessee 38120
    United States

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  • Nashville, Tennessee 37203
    United States

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  • Austin, Texas 78731
    United States

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  • Bedford, Texas 76022
    United States

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  • Dallas, Texas 75246
    United States

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  • Fort Worth, Texas 76104
    United States

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  • Houston, Texas 77024
    United States

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  • San Antonio, Texas 78229
    United States

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  • Salt Lake City, Utah 84112
    United States

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  • Seattle, Washington 98109
    United States

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  • Vancouver, Washington 98684
    United States

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  • Yakima, Washington 98902
    United States

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