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A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
This study has been completed.
First Received: March 14, 2005   Last Updated: June 4, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00105443
  Purpose

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall Survival & Time to Symptomatic Progression [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to Progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes (PRO) as measured by total score on FACT-Hep [ Time Frame: Cycle 1 Day 1, Cycle 3 Day 1, EOT visit ] [ Designated as safety issue: No ]

Enrollment: 602
Study Start Date: March 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Active Comparator Drug: Nexavar (Sorafenib, BAY43-9006)
400 mg BID BAY 43-9006
Arm 2: Placebo Comparator Drug: Placebo
400 mg BID Placebo

  Eligibility

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

Inclusion Criteria:

  • Ages eligible for study: 18 years and above, Genders eligible for study: both
  • Patients who have a life expectancy of at least 12 weeks
  • Patients with histologically or cytologically documented HCC
  • Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (2) Not previously treated with local therapy
  • Patients who have an ECOG PS of 0, 1, or 2

Exclusion Criteria:

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
  • Renal failure requiring hemo- or peritoneal dialysis
  • History of cardiac disease
  • Active clinically serious infections
  • Known history of human immunodeficiency virus (HIV) infection
  • Known central nervous system tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105443

  Show 183 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 100554, EudraCT No: 2004-001773-26, SHARP
Study First Received: March 14, 2005
Last Updated: June 4, 2009
ClinicalTrials.gov Identifier: NCT00105443     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Liver Cancer
Cancer

Additional relevant MeSH terms:
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Hepatocellular
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010