Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
NCT ID: NCT01908426
Last Updated: 2021-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
707 participants
INTERVENTIONAL
2013-09-26
2021-01-12
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
QUADRUPLE
Study Groups
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Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily
Cabozantinib tablets
Placebo
Oral cabozantinib-matched placebo tablet once daily
Placebo tablets
Interventions
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Cabozantinib tablets
Placebo tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Corona, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Burlington, Massachusetts, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
East Orange, New Jersey, United States
New York, New York, United States
New York, New York, United States
Valhalla, New York, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Camperdown, New South Wales, Australia
Concord, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Westmead, New South Wales, Australia
Kurralta Park, South Australia, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Edegem, Antwerpen, Belgium
La Louvière, Hainaut, Belgium
Ghent, Oost-Vlaanderen, Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Nice, Alpes-Maritimes, France
Amiens, Somme, France
Créteil, Val-de-Marne, France
Besançon, , France
Bordeaux, , France
Clermont-Ferrand, , France
Lille, , France
Lyon, , France
Esslingen am Neckar, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, , Germany
Freiburg im Breisgau, , Germany
Hong Kong, , Hong Kong
Dublin, , Ireland
Bologna, Emilia-Romagna, Italy
Faenza, Emilia-Romagna, Italy
Meldola, Emilia-Romagna, Italy
Rimini, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Rozzano, Lombardy, Italy
Palermo, Sicily, Italy
Padua, Veneto, Italy
Maastricht, Limburg, Netherlands
Amsterdam, North Holland, Netherlands
Amsterdam, North Holland, Netherlands
Leiden, South Holland, Netherlands
Auckland, North Island, New Zealand
Olsztyn, Warmian-Masurian Voivodeship, Poland
Mysłowice, , Poland
Poznan, , Poland
Cluj-Napoca, Cluj, Romania
Brasov, , Romania
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Goyang, Gyeonggido, South Korea
Busan, , South Korea
Seongnam, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Elche, Alicante, Spain
Majadahonda, Madrid, Spain
Torrejón de Ardoz, Madrid, Spain
Madrid, , Spain
Madrid, , Spain
Zaragoza, , Spain
Liuying Township, Tainan, Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Edirne, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Metropolitan Borough of Wirral, England, United Kingdom
Birmingham, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Freemantle N, Mollon P, Meyer T, Cheng AL, El-Khoueiry AB, Kelley RK, Baron AD, Benzaghou F, Mangeshkar M, Abou-Alfa GK. Quality of life assessment of cabozantinib in patients with advanced hepatocellular carcinoma in the CELESTIAL trial. Eur J Cancer. 2022 Jun;168:91-98. doi: 10.1016/j.ejca.2022.03.021. Epub 2022 Apr 26.
El-Khoueiry AB, Meyer T, Cheng AL, Rimassa L, Sen S, Milwee S, Kelley RK, Abou-Alfa GK. Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child-Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial. BMC Cancer. 2022 Apr 9;22(1):377. doi: 10.1186/s12885-022-09453-z.
Kelley RK, Miksad R, Cicin I, Chen Y, Klumpen HJ, Kim S, Lin ZZ, Youkstetter J, Hazra S, Sen S, Cheng AL, El-Khoueiry AB, Meyer T, Abou-Alfa GK. Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade. Br J Cancer. 2022 Mar;126(4):569-575. doi: 10.1038/s41416-021-01532-5. Epub 2021 Oct 7.
Trojan J, Mollon P, Daniele B, Marteau F, Martin L, Li Y, Xu Q, Piscaglia F, Zaucha R, Sarker D, Lim HY, Venerito M. Comparative Efficacy of Cabozantinib and Ramucirumab After Sorafenib for Patients with Hepatocellular Carcinoma and Alpha-fetoprotein >/= 400 ng/mL: A Matching-Adjusted Indirect Comparison. Adv Ther. 2021 May;38(5):2472-2490. doi: 10.1007/s12325-021-01700-2. Epub 2021 Apr 6.
Kelley RK, Ryoo BY, Merle P, Park JW, Bolondi L, Chan SL, Lim HY, Baron AD, Parnis F, Knox J, Cattan S, Yau T, Lougheed JC, Milwee S, El-Khoueiry AB, Cheng AL, Meyer T, Abou-Alfa GK. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open. 2020 Aug;5(4):e000714. doi: 10.1136/esmoopen-2020-000714.
Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klumpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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XL184-309
Identifier Type: -
Identifier Source: org_study_id
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