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

Last updated: April 8, 2021
Sponsor: Exelixis
Overall Status: Completed

Phase

3

Condition

Carcinoma

Liver Disease

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT01908426
XL184-309
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 definedlaboratory 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 acceptedmethods of contraception during the course of the study and for 4 months after thelast dose of study treatment.
  11. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion

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 beforerandomization.
  4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) orradionuclide treatment within 6 weeks of randomization.
  5. Prior cabozantinib treatment.
  6. Known brain metastases or cranial epidural disease unless adequately treated withradiotherapy 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 forbleeding.
  10. Moderate or severe ascites.
  11. Pregnant or lactating females.
  12. Diagnosis of another malignancy within 2 years before randomization, except forsuperficial skin cancers, or localized, low-grade tumors.

Study Design

Total Participants: 707
Study Start date:
September 26, 2013
Estimated Completion Date:
January 12, 2021

Connect with a study center

  • Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Concord, New South Wales 2139
    Australia

    Site Not Available

  • Darlinghurst, New South Wales 2010
    Australia

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  • Kogarah, New South Wales 2217
    Australia

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  • Westmead, New South Wales 2145
    Australia

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  • Kurralta Park, South Australia 5037
    Australia

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  • Melbourne, Victoria 3050
    Australia

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  • Perth, Western Australia 6000
    Australia

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    Adelaide,
    Australia

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    Cairns,
    Australia

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    Sydney,
    Australia

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  • Edegem, Antwerpen 2650
    Belgium

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  • La Louvière, Hainaut 7100
    Belgium

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  • Gent, Oost-Vlaanderen 9000
    Belgium

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    Haine-Saint-Paul, 7100
    Belgium

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    La Louviere,
    Belgium

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  • Liege, 4000
    Belgium

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    Salvador Bahia,
    Brazil

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    Sao Paulo,
    Brazil

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  • Calgary, Alberta T2N 4N2
    Canada

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  • Toronto, Ontario M5G 2M9
    Canada

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    Montreal, Quebec H2X 3J4
    Canada

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  • Saskatoon, Saskatchewan S7N 4H4
    Canada

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  • Nice, Alpes-Maritimes 6202
    France

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  • Amiens, Somme 80054
    France

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  • Creteil, Val-de-Marne 94010
    France

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    Angers,
    France

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    Belfort,
    France

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  • Besançon, 25000
    France

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  • Bordeaux, 33075
    France

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    Clermont Ferrand,
    France

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  • Clermont-Ferrand, 63003
    France

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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, 59037
    France

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  • Lyon, 69317
    France

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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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    Villejuif,
    France

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    Tbilisi,
    Georgia

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  • Esslingen am Neckar, Baden-Württemberg 73730
    Germany

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  • Tübingen, Baden-Württemberg 72076
    Germany

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  • München, Bayern 81675
    Germany

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  • Frankfurt am Main, Hessen 60590
    Germany

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  • Magdeburg, Sachsen-Anhalt 39120
    Germany

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  • Berlin, 13353
    Germany

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    Frankfurt,
    Germany

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  • Freiburg,
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    Leipzig,
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    Mannehim,
    Germany

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    Ulm,
    Germany

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    Wuppertal,
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    Hong Kong

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    Kowloon,
    Hong Kong

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  • Dublin, 7
    Ireland

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  • Bologna, Emilia-Romagna 40138
    Italy

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  • Faenza, Emilia-Romagna 48018
    Italy

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  • Meldola, Emilia-Romagna 47014
    Italy

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  • Rimini, Emilia-Romagna 47900
    Italy

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  • Roma, Lazio 168
    Italy

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  • Genova, Liguria 16132
    Italy

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  • Milan, Lombardia 20122
    Italy

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  • Rozzano, Lombardia 20089
    Italy

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  • Palermo, Sicilia 90127
    Italy

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  • Padova, Veneto 35128
    Italy

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    Bari,
    Italy

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    Benevento,
    Italy

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    Milano,
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    Ravenna,
    Italy

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  • Goyang, Gyeonggido 410-769
    Korea, Republic of

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  • Busan, 602-739
    Korea, Republic of

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    Jongno-Gu,
    Korea, Republic of

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    Pusan,
    Korea, Republic of

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  • Seongnam, 463-707
    Korea, Republic of

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  • Seoul, 120-752
    Korea, Republic of

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    Suwon,
    Korea, Republic of

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  • Suwon-si, 443-721
    Korea, Republic of

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    Mexico City,
    Mexico

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    Puebla,
    Mexico

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  • Maastricht, Limburg 6229 HX
    Netherlands

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  • Amsterdam, Noord-Holland 1081 HV
    Netherlands

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  • Leiden, Zuid-Holland 2333 ZA
    Netherlands

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  • Auckland, North Island 1003
    New Zealand

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  • Olsztyn, Warminsko-Mazurskie 10-513
    Poland

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  • Myslowice, 41-400
    Poland

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  • Poznan, 60-569
    Poland

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    Szczecin,
    Poland

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  • Cluj-Napoca, Cluj 400015
    Romania

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  • Brasov, 500019
    Romania

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    Cluj Napoca,
    Romania

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  • Singapore, 119074
    Singapore

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  • Elche, Alicante 3293
    Spain

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  • Majadahonda, Madrid 28222
    Spain

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  • Torrejon de Ardoz, Madrid 28850
    Spain

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  • Madrid, 28007
    Spain

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  • Zaragoza, 50009
    Spain

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  • Liuying Township, Tainan 736
    Taiwan

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    Kaohsiung,
    Taiwan

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  • Taichung, 40705
    Taiwan

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    Taichung City,
    Taiwan

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    Tainan,
    Taiwan

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  • Taipei, 100
    Taiwan

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    Taipei City,
    Taiwan

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    Taoyuan,
    Taiwan

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    Edime,
    Turkey

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  • Edirne, 22030
    Turkey

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  • Gaziantep, 27100
    Turkey

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    Istanbul,
    Turkey

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  • Wirral, England CH63 4JY
    United Kingdom

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    Belfast,
    United Kingdom

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  • Birmingham, B15 2TH
    United Kingdom

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  • London, SE5 9RS
    United Kingdom

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  • Manchester, M20 4BX
    United Kingdom

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  • Corona, California 92879
    United States

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  • Los Angeles, California 90033
    United States

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  • San Diego, California 92123
    United States

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  • San Francisco, California 94115
    United States

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  • Gainesville, Florida 32610
    United States

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  • Atlanta, Georgia 30318
    United States

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  • Honolulu, Hawaii 96815
    United States

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  • Chicago, Illinois 60637
    United States

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  • Burlington, Massachusetts 01805
    United States

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    Minneapolis, Minnesota
    United States

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  • Rochester, Minnesota 55905
    United States

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  • Kansas City, Missouri 64128
    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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  • Las Vegas, Nevada 89109
    United States

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  • East Orange, New Jersey 07018
    United States

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  • New York, New York 10065
    United States

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  • Valhalla, New York 10595
    United States

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  • Dallas, Texas 75246
    United States

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  • San Antonio, Texas 78215
    United States

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  • Seattle, Washington 98109
    United States

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  • Spokane, Washington 99208
    United States

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