Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Exelixis
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01908426
First received: July 23, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Cabozantinib (XL184)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]
    OS is defined as the time from randomization to death from any cause.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]
    Duration of PFS is defined as the time of randomization to the earlier of the following events: progressive disease or death due to any cause.

  • Objective Response Rate (ORR) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]
    ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment. ORR is the proportion of subjects experiencing a confirmed complete response(CR) or confirmed partial response (PR).


Estimated Enrollment: 760
Study Start Date: August 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184): oral cabozantinib tablet once a day
Drug: Cabozantinib (XL184)
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo tablet once daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Select Inclusion Criteria:

  1. Histological or cytological diagnosis of HCC.
  2. The subject has disease that is not amenable to a curative treatment approach.
  3. Received prior sorafenib.
  4. Progression following at least 1 prior systemic treatment for HCC.
  5. Recovery to from toxicities related to any prior treatments.
  6. ECOG performance status of 0 or 1.
  7. Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
  8. Child-Pugh Score of A.
  9. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
  10. 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.
  11. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

  1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  2. Receipt of more than 2 prior systemic therapies for advanced HCC.
  3. Any type of anticancer agent (including investigational) within 2 weeks before randomization.
  4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
  5. Prior cabozantinib treatment.
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  7. Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
  8. Serious illness other than cancer that would preclude safe participation in the study.
  9. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
  10. Moderate or severe ascites.
  11. Pregnant or lactating females.
  12. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908426

Contacts
Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494)
Contact: Backup or International 650-837-7400

  Hide Study Locations
Locations
United States, California
Recruiting
Corona, California, United States, 92879
Contact: Dean Bosman    714-698-0300    dean.bosman@clinicaidusa.com   
Recruiting
Los Angeles, California, United States, 90033
Contact: Catherine Ticong    323-865-0460    catherine.ticong@med.usc.edu   
Recruiting
San Diego, California, United States, 92123
Recruiting
San Francisco, California, United States, 94115
Contact: Hilary Chan    415-514-5633    ChanH@cc.ucsf.edu   
Recruiting
San Francisco, California, United States, 94115
Contact: Brenda Eng    415-600-1775    EngB@cpmcri.org   
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30318
Contact: Michelle Humphreys    404-425-7943    michelle.humphreys@piedmont.org   
United States, Hawaii
Recruiting
Honolulu, Hawaii, United States, 96815
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60637
Contact: Tamika Harris       tharris@bsd.uchicago.edu   
United States, Massachusetts
Recruiting
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Not yet recruiting
Minneapolis, Minnesota, United States
Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jodi Klocke    507-538-4545    klocke.jodi@mayo.edu   
United States, Missouri
Recruiting
Kansas City, Missouri, United States, 64128
Contact: Sarah Spencer    816-861-4700 ext 57665    sarah.spencer@va.gov   
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St. Louis, Missouri, United States, 63110
United States, Nevada
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Las Vegas, Nevada, United States, 89109
United States, New Jersey
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East Orange, New Jersey, United States
United States, New York
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New York, New York, United States, 10065
Contact: Ghassan Abou-Alfa    646-888-4184    abou-alg@mskcc.org   
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New York, New York, United States, 10032
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Valhalla, New York, United States, 10595
Contact: Michael Fanucchi    914-493-2220    fanucchim@wcmc.com   
United States, Texas
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Dallas, Texas, United States, 75246
Contact: Referral Office    972-566-3000    referral@marycrowley.org   
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San Antonio, Texas, United States, 78215
Contact: Samantha Galley    210-253-3426    sgalley@txliver.com   
United States, Washington
Recruiting
Seattle, Washington, United States, 98109
Contact: Grace Gyurkey    206-288-7603    ggyurkey@seattlecca.org   
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Seattle, Washington, United States, 98104
Contact: Research Nurse    206-215-3086    CancerResearch@Swedish.org   
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Spokane, Washington, United States, 99208
Contact: Monika Chaudhry    509-462-2273    chaudhrym@nwrm.com   
Australia, New South Wales
Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Simone Strasser    +61 2 9515 7606    strassers@email.cs.nsw.gov.au   
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Concord, New South Wales, Australia, 2139
Contact: Alice Lee    +61 2 9767 5563    Melissa.Kermeen@sswahs.nsw.gov.au   
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Darlinghurst, New South Wales, Australia, 2010
Contact: Mark Danta    +61 2 8382 3302    m.danta@unsw.edu.au   
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Kogarah, New South Wales, Australia, 2217
Contact: Amany Zekry         
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Westmead, New South Wales, Australia, 2145
Contact: Jacob George    +61 2 9845 7705    sengkee.teo@sydney.edu.au   
Australia, South Australia
Recruiting
Kurralta Park, South Australia, Australia, 5037
Contact: Francis Parnis    +61 8 8292 2240    hdaykin@adelaidecancercentre.com.au   
Australia, Victoria
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Melbourne, Victoria, Australia, 3050
Contact: Amanda Nicoll    +61 3 9342 7789    amanda.nicoll@mh.org.au   
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Contact: Nickolas Kontorinis    +61 8 9224 3348    nick.kontorinis@health.wa.gov.au   
Australia
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Cairns, Australia
Belgium
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Edegem, Antwerpen, Belgium, 2650
Contact: Véronique Derwael    +32 3 821 52 10    Veronique.Derwael@uza.be   
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La Louvière, Hainaut, Belgium, 7100
Contact: Joelle Ndem Baroung    +32 64 23 39 87    Joelle.Ndembaroung@entitejolimontoise.be   
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Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Hans Van Vlierberghe, Prof Dr    +32 9 332 94 59    hans.vanvlierberghe@ugent.be   
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Liege, Belgium, 4000
Contact: Jean Delwaide, MD    +32 4 366 72 56      
Brazil
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Salvador Bahia, Brazil
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Sao Paulo, Brazil
Canada, Ontario
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Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
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Montreal, Quebec, Canada, H2X 3J4
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Montreal, Quebec, Canada, H3T 1E2
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Rose Jackson    306-655-2777    rose.jackson@saskcancer.ca   
France
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Nice, Alpes-Maritimes, France, 6202
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Amiens, Somme, France, 80054
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Creteil, Val-de-Marne, France, 94010
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Angers, France
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Belfort, France
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Bordeaux, France, 33075
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Clermont-Ferrand, France, 63003
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Clichy, France
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Colmar, France
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Dijon, France
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Grenoble, France
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Lille, France, 59037
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Lyon, France, 69317
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Marseille, France
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Pringy, France
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Reims, France
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Rennes, France
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Germany
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Esslingen am Neckar, Germany
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Leipzig, Germany
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Munich, Germany
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Tuebingen, Germany
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Ulm, Germany
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Wuppertal, Germany
Hong Kong
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Hong Kong, Hong Kong
Contact: Stephen Chan    +852 2632 2118    chanlam_stephen@cuhk.edu.hk   
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
Ireland
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Dublin, Ireland, 7
Italy
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Bologna, Emilia-Romagna, Italy, 40138
Contact: Luigi Bolondi    +39 051 6362260    luigi.bolondi@unibo.it   
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Faenza, Emilia-Romagna, Italy, 48018
Contact: Stefano Tamberi    +39 0546 601274    s.tamberi@ausl.ra.it   
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Rimini, Emilia-Romagna, Italy, 47900
Contact: Emiliano Tamburini    +39 0541 705413    emilianotamburini@yahoo.it   
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Roma, Lazio, Italy, 168
Contact: Antonio Gasbarrini    +39 06 30156018    agasbarrini@rm.unicatt.it   
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Roma, Lazio, Italy, 128
Contact: Giuseppe Tonini    +39 06 225411201    g.tonini@unicampus.it   
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Milan, Lombardia, Italy, 20122
Contact: Massimo Colombo    + 39 02 55035432    massimo.colombo@unimi.it   
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Rozzano, Lombardia, Italy, 20089
Contact: Armando Santoro    +39 02 82244080    armando.santoro@humanitas.it   
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Palermo, Sicilia, Italy, 90127
Contact: Antonio Craxi    +39 091 6552280    antonio.craxi@unipa.it   
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Padova, Veneto, Italy, 35128
Contact: Fabio Farinati    +39 049 8211305    fabio.farinati@unipd.it   
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Bari, Italy
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Benevento, Italy
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Genova, Italy
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Meldola, Italy
Korea, Republic of
Recruiting
Goyang, Gyeonggido, Korea, Republic of, 410-769
Contact: JoongWon Park    +82 31 920 1605    jwpark@ncc.re.kr   
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Busan, Korea, Republic of, 602-739
Contact: Jeong Heo    +82 51 240 7869    jheo@pusan.ac.kr   
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Seongnam, Korea, Republic of, 463-707
Contact: Jeehyun Kim    +82 31 787 7022    jhkimmd@snu.ac.kr   
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Seoul, Korea, Republic of, 138-736
Contact: Baek-yeol Ryoo    +82 2 3010 3211    ryooby@amc.seoul.kr   
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Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Hoogeun Chun    +82 2 2258 1074    hgchun@catholic.ac.kr   
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Seoul, Korea, Republic of, 136-705
Contact: YeulHong Kim    +82 2 9205 569    yhk0215@korea.ac.kr   
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-710
Contact: Ho Yeong Lim    +82 2 3410 0914    hoylim@skku.edu   
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Suwon-si, Korea, Republic of, 443-721
Contact: Sung-Won Cho    +82 31 219 5106    sung_woncho@hotmail.com   
Mexico
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Mexico City, Mexico
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Puebla, Mexico
Netherlands
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Maastricht, Limburg, Netherlands, 6229 HX
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Amsterdam, Noord-Holland, Netherlands, 1105 AZ
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Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: M.J.D.L. van der Vorst, MD    +31 20 4441295    m.vandervorst@vumc.nl   
Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Jeanne van Steijn    +31 71 5269111 ext 9661    A.Q.M.J.van_Stejn-van_Tol@lumc.nl   
New Zealand
Recruiting
Auckland, North Island, New Zealand, 1003
Contact: Edward Gane    +64 2154 8371    edgane@adhb.govt.nz   
Poland
Recruiting
Olsztyn, Warminsko-Mazurskie, Poland, 10-513
Contact: Joanna Roszak    +48 89 513 5548    joanna.roszak@gazeta.pl   
Recruiting
Myslowice, Poland, 41-400
Contact: Paulina Michnicka    +48 32 616 1394    paulina245@gazeta.pl   
Recruiting
Poznan, Poland, 60-569
Contact: Kinga Osowiecka    +48 61 854 9028    kinga-osowiecka@o2.pl   
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Szczecin, Poland
Romania
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Cluj-Napoca, Cluj, Romania, 400015
Contact: Anca Mihailov       mihailovanca@yahoo.com   
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Brasov, Romania, 500019
Contact: Eugeniu Banu       eugeniu.banu@spitalulsfconstantin.ro   
Not yet recruiting
Cluj-Napoca, Romania
Singapore
Recruiting
Singapore, Singapore, 308433
Contact: Alex Yuang-Chi Chang    +65 6880 2213    alexchang@imc.jhmi.edu   
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Singapore, Singapore, 119074
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Singapore, Singapore, 169610
Contact: Su Pin Choo    +65 6436 8000    margaret.tan.s.t@nccs.com.sg   
Spain
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Elche, Alicante, Spain, 3293
Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Ana Ruiz Casado    +34 91 191 6279    arcasado@salud.madrid.org   
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Torrejon de Ardoz, Madrid, Spain, 28850
Contact: Luis Cabezon Gutierrez    +34 61 868 23 54    lcabezon@torrejonsalud.com   
Recruiting
Madrid, Spain, 28041
Contact: Jose Antonio Lopez Martin         
Recruiting
Madrid, Spain, 28007
Contact: Andres J Muñoz Martín    +34 91 426 93 94    beatrizpuente.hgugm@yahoo.es   
Recruiting
Madrid, Spain, 28007
Recruiting
Zaragoza, Spain, 50009
Contact: Roberto A Pazo Cid    +34 976 76 5500 ext 1187    rapazocid@seom.org   
Taiwan
Recruiting
Liuying Township, Tainan, Taiwan, 736
Contact: Yen-Hsun Chen         
Not yet recruiting
Kaohsiung, Taiwan
Recruiting
Taichung, Taiwan, 40705
Contact: Sheng-Shun Yang         
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Taichung, Taiwan
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Tainan, Taiwan
Recruiting
Taipei, Taiwan, 100
Contact: Zhong-Zhe Lin         
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Taipei, Taiwan
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Taipei City, Taiwan
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Taoyuan, Taiwan
Turkey
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Edirne, Turkey, 22030
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Gaziantep, Turkey, 27100
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Istanbul, Turkey
United Kingdom
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Wirral, England, United Kingdom, CH63 4JY
Not yet recruiting
Belfast, United Kingdom
Not yet recruiting
Birmingham, United Kingdom
Recruiting
London, United Kingdom, SE5 9RS
Contact: Jozer Calara    +44 20 3299 9000    jozer.calara@nhs.net   
Recruiting
London, United Kingdom, NW3 2QG
Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Juan Valle         
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01908426     History of Changes
Other Study ID Numbers: XL184-309
Study First Received: July 23, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
cabozantinib
XL184
liver cancer
hepatocellular carcinoma
tyrosine kinase inhibitor
MET
vascular endothelial growth factor receptor 2 (VEGFR2)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014