A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Carcinoma, Hepatocellular
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:
Interventional
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:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
10874
NCT ID:
NCT00044512
Start Date:
August 2002
Completion Date:
February 2008
Related Keywords:
- Carcinoma, Hepatocellular
- Cancer
- Liver Cancer
- Hepatocellular carcinoma (HCC)
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Albany, New York 12208 |
