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A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044512
Recruitment Status : Completed
First Posted : September 4, 2002
Results First Posted : August 6, 2009
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):

Brief Summary:
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006) Phase 2

Detailed Description:

In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

  • Pharmacokinetics (PK) profile of Sorafenib
  • Plasma and tissue tumor biomarkers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : August 2002
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sorafenib 400 mg b.i.d.
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Primary Outcome Measures :
  1. Percentage of Participants for Each Type of Response [ Time Frame: Until 30 days after termination of active therapy ]
    Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: up to 3 years later ]
    Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.

  2. Time to Response [ Time Frame: up to 3 years later ]
    Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).

  3. Time to Progression [ Time Frame: up to 3 years later ]
    Time from the first date of receiving study drug until the first documented PD.

  4. Duration of Stable Disease [ Time Frame: up to 3 years later ]
    Time from the first day of receiving study drug until there was a documented PD or response.

  5. Time to Minor Response [ Time Frame: up to 3 years later ]
    Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.

  6. Duration of Minor Response [ Time Frame: Time from MR to PD ]
    Time from the date that MR was first documented to the date that PD was first documented.

  7. Overall Survival [ Time Frame: Start of treatment to death ]
    Time from the first date of receiving study medication to death.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
  • 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:

  • Fibrolamellar disease mixed histology
  • Metastatic brain or meningeal tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044512

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United States, California
Los Angeles, California, United States, 90057
United States, New York
New York, New York, United States, 10021-6007
Bruxelles - Brussel, Belgium, 1000
Bruxelles - Brussel, Belgium, 1070
Bruxelles - Brussel, Belgium, 1090
Gent, Belgium, 9000
Leuven, Belgium, 3000
Lille Cedex, France, 59020
Marseille, France, 13005
Paris, France, 75020
Rennes Cedex, France, 35062
Saint Herblain, France, 44805
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Petach Tikva, Israel, 49100
Rehovot, Israel, 76100
Tel Aviv, Israel, 64239
Tel Hashomer, Israel, 52621
Rozzano, Milano, Italy, 20089
Forlì, Italy, 47100
Milano, Italy, 20122
Pisa, Italy, 56126
Verona, Italy, 37126
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Publications of Results:
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Responsible Party: Bayer Identifier: NCT00044512    
Obsolete Identifiers: NCT00048919, NCT00058383
Other Study ID Numbers: 10874
First Posted: September 4, 2002    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: April 16, 2014
Last Verified: March 2014
Keywords provided by Bayer:
Liver Cancer
Hepatocellular carcinoma (HCC)
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action