A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT00108953
Last Updated: 2014-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2005-04-30
2008-04-30
Brief Summary
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Detailed Description
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The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sorafenib + Doxorubicin
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Multi kinase inhibitor plus Chemotherapy
Placebo + Doxorubicin
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Doxorubicin/Placebo
Chemotherapy plus Placebo
Interventions
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Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Multi kinase inhibitor plus Chemotherapy
Doxorubicin/Placebo
Chemotherapy plus Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
* Patients must have at least one tumor lesion that meets both of the following criteria:
* can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
* has not been previously treated with local therapy
* Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
* Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
* History of cardiac disease
* Serious myocardial dysfunction
* Active, clinically serious infections
* Known history of Human Immunodeficiency Virus (HIV) infection
* Known Central Nervous System (CNS) 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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Birmingham, Alabama, United States
Beverly Hills, California, United States
Orange, California, United States
Palo Alto, California, United States
San Francisco, California, United States
San Francisco, California, United States
Sylmar, California, United States
Miami, Florida, United States
Lafayette, Louisiana, United States
Minneapolis, Minnesota, United States
Hackensack, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Nashville, Tennessee, United States
Seattle, Washington, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Neuquén, Neuquén Province, Argentina
Buenos Aires, , Argentina
Toronto, Ontario, Canada
Hong Kong, Hong Kong, Hong Kong
Kazan', , Russia
Kirov, , Russia
Krasnodar, , Russia
Maidstone, Kent, United Kingdom
London, London, United Kingdom
Manchester, Manchester, United Kingdom
Bebington, Merseyside, United Kingdom
Birmingham, West Midlands, United Kingdom
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, Johnson P, Knox JJ, Capanu M, Davidenko I, Lacava J, Leung T, Gansukh B, Saltz LB. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma: a randomized trial. JAMA. 2010 Nov 17;304(19):2154-60. doi: 10.1001/jama.2010.1672.
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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2004-001770-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11546
Identifier Type: -
Identifier Source: org_study_id
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