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Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00494299
First received: June 28, 2007
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.


Condition Intervention Phase
Carcinoma, Hepatocellular
 Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to Progression (TTP) [ Time Frame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months. ] [ Designated as safety issue: No ]
    Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From randomization of the first subject until 39 months later. ] [ Designated as safety issue: No ]
    Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis.


Enrollment: 458
Study Start Date: April 2006
Study Completion Date: November 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
 Drug: Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo Comparator: Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
 Drug: Placebo
Placebo: matching placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Aged of 18 and over
  • Advanced hepatocellular carcinoma

Exclusion Criteria:

  • History of prior systemic chemotherapy
  • Failure in vital organ
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494299

  Show 75 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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Publications:

Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT00494299     History of Changes
Other Study ID Numbers: 11721
Study First Received: June 28, 2007
Results First Received: December 21, 2010
Last Updated: November 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration

Keywords provided by Bayer:
HCC
Cancer
Liver Cancer
TACE

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013