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

March 26, 2014 updated by: Bayer

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1000
      • Bruxelles - Brussel, Belgium, 1090
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
  • France
      • Lille Cedex, France, 59020
      • Marseille, France, 13005
      • Paris, France, 75020
      • Rennes Cedex, France, 35062
      • Saint Herblain, France, 44805
  • Israel
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Petach Tikva, Israel, 49100
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
  • Italy
      • Forlì, Italy, 47100
      • Milano, Italy, 20122
      • Pisa, Italy, 56126
      • Verona, Italy, 37126
    • Milano
      • Rozzano, Milano, Italy, 20089
  • United States
    • California
      • Los Angeles, California, United States, 90057
    • New York
      • New York, New York, United States, 10021-6007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib 400 mg b.i.d.
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants for Each Type of Response
Time Frame: Until 30 days after termination of active therapy
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.
Until 30 days after termination of active therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response
Time Frame: up to 3 years later
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.
up to 3 years later
Time to Response
Time Frame: up to 3 years later
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
up to 3 years later
Time to Progression
Time Frame: up to 3 years later
Time from the first date of receiving study drug until the first documented PD.
up to 3 years later
Duration of Stable Disease
Time Frame: up to 3 years later
Time from the first day of receiving study drug until there was a documented PD or response.
up to 3 years later
Time to Minor Response
Time Frame: up to 3 years later
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
up to 3 years later
Duration of Minor Response
Time Frame: Time from MR to PD
Time from the date that MR was first documented to the date that PD was first documented.
Time from MR to PD
Overall Survival
Time Frame: Start of treatment to death
Time from the first date of receiving study medication to death.
Start of treatment to death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 30, 2002

First Submitted That Met QC Criteria

September 3, 2002

First Posted (Estimate)

September 4, 2002

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10874

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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