A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
NCT ID: NCT00044512
Last Updated: 2014-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2002-08-31
2008-02-29
Brief Summary
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Detailed Description
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* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sorafenib 400 mg b.i.d.
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Eligibility Criteria
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Inclusion Criteria
* Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
* Measurable disease
* At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
* Presence of at least 1 of the following:
* Alpha-fetoprotein greater than the upper limit of normal (ULN)
* Hepatitis C antibody positive
* Hepatitis B surface antigen positive
* Child's Pugh class A or B
* Candidate for systemic therapy
Exclusion Criteria
* Metastatic brain or meningeal tumors
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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Los Angeles, California, United States
New York, New York, United States
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Lille, , France
Marseille, , France
Paris, , France
Rennes, , France
Saint-Herblain, , France
Haifa, Israel, Israel
Jerusalem, Israel, Israel
Petah Tikva, Israel, Israel
Rehovot, Israel, Israel
Tel Aviv, Israel, Israel
Tel Litwinsky, , Israel
Rozzano, Milano, Italy
Forlì, , Italy
Milan, , Italy
Pisa, , Italy
Verona, , Italy
Countries
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References
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Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4.
Other Identifiers
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10874
Identifier Type: -
Identifier Source: org_study_id
NCT00048919
Identifier Type: -
Identifier Source: nct_alias
NCT00058383
Identifier Type: -
Identifier Source: nct_alias
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