ClinicalTrials.gov
History of Changes for Study: NCT00105443
A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma
Latest version (submitted October 24, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 26, 2005 None (earliest Version on record)
2 July 27, 2005 Study Status and Contacts/Locations
3 August 2, 2005 Study Status and Contacts/Locations
4 August 9, 2005 Contacts/Locations and Study Status
5 September 9, 2005 Contacts/Locations and Study Status
6 September 22, 2005 Contacts/Locations and Study Status
7 September 23, 2005 Contacts/Locations and Study Status
8 September 26, 2005 Contacts/Locations and Study Status
9 November 16, 2005 Study Status, Contacts/Locations and Study Identification
10 April 5, 2006 Recruitment Status, Study Status and Contacts/Locations
11 September 27, 2006 Eligibility, Study Design, Study Status, Contacts/Locations, Arms and Interventions, Conditions, Study Description and Study Identification
12 October 24, 2008 Contacts/Locations, Study Status, Arms and Interventions, Study Design, Conditions, Study Identification, Eligibility, Outcome Measures, Oversight and Sponsor/Collaborators
13 January 29, 2009 Recruitment Status, Contacts/Locations, Study Status and Arms and Interventions
14 June 4, 2009 Conditions and Study Status
15 September 7, 2010 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Results, Eligibility and Study Description
16 January 17, 2011 Outcome Measures, Adverse Events, Participant Flow, Arms and Interventions, Study Status, Baseline Characteristics
17 January 26, 2012 Contacts/Locations, Study Status and Study Identification
18 April 3, 2013 Study Status, References, Contacts/Locations and Sponsor/Collaborators
19 March 27, 2014 Sponsor/Collaborators, Study Status and Baseline Characteristics
20 October 24, 2014 Study Status and References
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Study NCT00105443
Submitted Date:  June 26, 2005 (v1)
Open or close this module Study Identification
Unique Protocol ID: 100554
Brief Title: A Research Study to Treat Patients with Advanced Hepatocellular Carcinoma
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2005
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: March 14, 2005
First Submitted that
Met QC Criteria:		 March 14, 2005
First Posted: March 15, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 26, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bayer
Responsible Party:
Collaborators:
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U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
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Brief Summary: The purpose of this phase III, randomized, placebo-controlled study is to evaluate the safety and efficacy of sorafenib versus placebo in patients with advanced hepatocellular carcinoma (HCC).
Detailed Description:
Open or close this module Conditions
Conditions: Hepatocellular Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Allocation: Randomized
Enrollment:
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Intervention Details:
Drug: BAY 43 9006 (sorafenib)
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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.
  • Other inclusion/exclusion criteria may apply.
Open or close this module Contacts/Locations
Locations: United States, California
Research Site
[Recruiting]
Los Angeles, California, United States, 90057
Contact:Contact: Sara Margiotta 213-989-1888 sara@kenmarresearch.com
Contact:Principal Investigator: Dr. Kennedy
Research Site
[Recruiting]
Los Angeles, California, United States
Contact:Contact: Lisa Yonemoto 310-825-4477 LYonemoto@mednet.ucla.edu
United States, New York
North Shore University Hospital / Division of Gastroenterology
[Recruiting]
Manhasset, New York, United States, 11030
Contact:Contact: Maly Tiev, RN 516-562-1364 mtiev@nshs.edu
Contact:Principal Investigator: Dr. David Bernstein
Mount Sinai School of Medicine
[Recruiting]
New York City, New York, United States
Contact:Contact: Catherine Burns, MA 212-241-7746 Catherine.burns@mountsinai.org
Contact:Principal Investigator: Josep M Llovet, MD
United States, Ohio
Gabrail Cancer Center
[Recruiting]
Canton, Ohio, United States, 44718
Contact:Contact: Carrie L Smith, RN 330-492-3345 Ext. 208
United States, Virginia
McGuire DVAMC GI (111N)
[Recruiting]
Richmond, Virginia, United States
Contact:Contact: Edie Gavis, RN 804-675-5021 edie.gavis@med.va.gov
United States, Washington
Swedish Cancer Institute
[Recruiting]
Seattle, Washington, United States, 98104
Contact:Contact: Jane Arthur, RN, MSN 206-386-6921 jane.arthur@swedish.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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