A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT00105443
Last Updated: 2014-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
602 participants
INTERVENTIONAL
2005-03-31
2008-11-30
Brief Summary
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Detailed Description
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* international normalized ratio (inr)
* Common Terminology Criteria for Adverse Events (ctcae)
* Not Otherwise Specified (nos)
* Gastrointestinal (gi)
* Central nervous system (cns)
* Absolute Neutrophil Count (anc)
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Creatine phosphokinase (cpk)
* Gammaglutamyltransferase (ggt)
* Genitourinary (gu)
* Atrioventricular (av)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Eligibility Criteria
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Inclusion Criteria
* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
* Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
* Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2
Exclusion Criteria
* Renal failure requiring hemo- or peritoneal dialysis
* History of cardiac disease
* Active clinically serious infections
* Known history of human immunodeficiency virus (HIV) infection
* Known central nervous system tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Stanford, California, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Canton, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Mar del Plata, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Bueno Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Camperdown, New South Wales, Australia
Randwick, New South Wales, Australia
Westmead, New South Wales, Australia
East Bentleigh, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Bruges, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Belo Horizonte, , Brazil
Belo Horizonte, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Santiago, Santiago Metropolitan, Chile
Santiago, , Chile
Santiago Región Metropolitana, , Chile
Zagreb, , Croatia
Bondy, , France
Bordeaux, , France
Clichy, , France
Dijon, , France
Lille, , France
Marseille, , France
Nantes, , France
Paris, , France
Rennes, , France
Vandœuvre-lès-Nancy, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Hanover, Lower Saxony, Germany
Bonn, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Haidari, Attica, Greece
Thessaloniki, Thessaloniki, Greece
Thessaloniki, Thessaloniki, Greece
Athens, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Petah Tikva, Israel, Israel
Tel Aviv, Israel, Israel
Zrifin, Israel, Israel
Haifa, , Israel
Forlì, Forlì, Italy
Rozzano, Milano, Italy
Avellino, , Italy
Bologna, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Palermo, , Italy
Pavia, , Italy
Pisa, , Italy
Roma, , Italy
Mexico City, Mexico City, Mexico
México, D.F., , Mexico
México, D.F., , Mexico
Monterrey, , Mexico
Auckland, , New Zealand
Wellington South, , New Zealand
Comas Lima, , Peru
Lima, , Peru
Lima Cercado, , Peru
Gdansk, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Iași, Iaşi, Romania
Timișoara, Timiș County, Romania
Craiova Dolj, , Romania
Kazan', , Russia
Kirov, , Russia
Krasnodar, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tolgliatti, , Russia
Yekaterinburg, , Russia
Yekaterinburg, , Russia
Alicante, Alicante, Spain
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Cruces/Barakaldo, Bilbao, Spain
Córdoba, Córdoba, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Pamplona, Pamplona, Spain
Valencia, Valencia, Spain
Bern, Canton of Bern, Switzerland
Geneva, Canton of Geneva, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Zurich, Canton of Zurich, Switzerland
Bristol, Avon, United Kingdom
London, London, United Kingdom
London, London, United Kingdom
Oxford, Oxfordshire, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
Wu W, Mao H, Song J, Yang F. Bibliometric analysis of hepatocellular carcinoma and tyrosine kinase inhibitors. Medicine (Baltimore). 2025 May 16;104(20):e42015. doi: 10.1097/MD.0000000000042015.
Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2004-001773-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
100554
Identifier Type: -
Identifier Source: org_study_id
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