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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Niacinamide; Sorafenib

Criteria

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