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

Bayer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044512

10874

Details and patient eligibility

About

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.

Full 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

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Sorafenib 400 mg b.i.d.

Experimental group

Description:

Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)