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

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ClinicalTrials.gov Identifier: NCT00494299
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : January 20, 2011
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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)
Study Start Date : April 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
    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 :
  1. Overall Survival (OS) [ Time Frame: From randomization of the first subject until 39 months later. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494299


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

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00494299     History of Changes
Other Study ID Numbers: 11721
First Posted: June 29, 2007    Key Record Dates
Results First Posted: January 20, 2011
Last Update Posted: December 20, 2013
Last Verified: November 2013

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
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs