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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00044512
First received: August 30, 2002
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of Participants for Each Type of Response [ Time Frame: Until 30 days after termination of active therapy ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Duration of Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
    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.

  • Time to Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
    Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).

  • Time to Progression [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
    Time from the first date of receiving study drug until the first documented PD.

  • Duration of Stable Disease [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
    Time from the first day of receiving study drug until there was a documented PD or response.

  • Time to Minor Response [ Time Frame: up to 3 years later ] [ Designated as safety issue: No ]
    Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.

  • Duration of Minor Response [ Time Frame: Time from MR to PD ] [ Designated as safety issue: No ]
    Time from the date that MR was first documented to the date that PD was first documented.

  • Overall Survival [ Time Frame: Start of treatment to death ] [ Designated as safety issue: No ]
    Time from the first date of receiving study medication to death.


Enrollment: 137
Study Start Date: August 2002
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044512

Locations
United States, California
Los Angeles, California, United States, 90057
United States, New York
New York, New York, United States, 10021-6007
Belgium
Bruxelles - Brussel, Belgium, 1000
Bruxelles - Brussel, Belgium, 1070
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
Rozzano, Milano, Italy, 20089
Forlì, Italy, 47100
Milano, Italy, 20122
Pisa, Italy, 56126
Verona, Italy, 37126
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00044512     History of Changes
Obsolete Identifiers: NCT00048919, NCT00058383
Other Study ID Numbers: 10874
Study First Received: August 30, 2002
Results First Received: February 20, 2009
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Cancer
Liver Cancer
Hepatocellular carcinoma (HCC)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014