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

Bayer137 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants for Each Type of Response

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.

Time frame: Until 30 days after termination of active therapy

Secondary Outcomes

Duration of Response

Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.