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

Completed · Phase 2

Conditions studied: Carcinoma, Hepatocellular

In brief

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.

Key facts

Study ID

NCT00044512

Run by

Bayer

People needed

137

Starts

2002-08-01

Expected to finish

2008-02-01

Last updated by the study team

2014-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Fibrolamellar disease mixed histology
• Metastatic brain or meningeal tumors

Where it is running

• Study site — Los Angeles, California, United States
• Study site — New York, New York, United States
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Lille, France
• Study site — Marseille, France
• Study site — Paris, France
• Study site — Rennes, France
• Study site — Saint-Herblain, France
• Study site — Haifa, Israel, Israel
• Study site — Jerusalem, Israel, Israel
• Study site — Petah Tikva, Israel, Israel
• Study site — Rehovot, Israel, Israel
• Study site — Tel Aviv, Israel, Israel
• Study site — Tel Litwinsky, Israel
• Study site — Rozzano, Milano, Italy
• Study site — Forlì, Italy
• Study site — Milan, Italy
• Study site — Pisa, Italy
• Study site — Verona, Italy

Full record on ClinicalTrials.gov

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