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A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants for Each Type of Response

Outcome Description:

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.

Outcome Time Frame:

Until 30 days after termination of active therapy

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

February 2008

Related Keywords:

  • Carcinoma, Hepatocellular
  • Cancer
  • Liver Cancer
  • Hepatocellular carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular



Fountain Valley, California  92708
Albany, New York  12208