A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
1 other identifier
interventional
137
5 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2002
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 30, 2002
CompletedFirst Posted
Study publicly available on registry
September 4, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
August 6, 2009
CompletedApril 16, 2014
March 1, 2014
5.5 years
August 30, 2002
February 20, 2009
March 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants for Each Type of Response
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.
Until 30 days after termination of active therapy
Secondary Outcomes (7)
Duration of Response
up to 3 years later
Time to Response
up to 3 years later
Time to Progression
up to 3 years later
Duration of Stable Disease
up to 3 years later
Time to Minor Response
up to 3 years later
- +2 more secondary outcomes
Study Arms (1)
Sorafenib 400 mg b.i.d.
EXPERIMENTALSorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Interventions
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (23)
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
New York, New York, 10021-6007, United States
Unknown Facility
Bruxelles - Brussel, 1000, Belgium
Unknown Facility
Bruxelles - Brussel, 1070, Belgium
Unknown Facility
Bruxelles - Brussel, 1090, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Lille, 59020, France
Unknown Facility
Marseille, 13005, France
Unknown Facility
Paris, 75020, France
Unknown Facility
Rennes, 35062, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Haifa, Israel, 31096, Israel
Unknown Facility
Jerusalem, Israel, 91120, Israel
Unknown Facility
Petah Tikva, Israel, 49100, Israel
Unknown Facility
Rehovot, Israel, 76100, Israel
Unknown Facility
Tel Aviv, Israel, 64239, Israel
Unknown Facility
Tel Litwinsky, 52621, Israel
Unknown Facility
Rozzano, Milano, 20089, Italy
Unknown Facility
Forlì, 47100, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Pisa, 56126, Italy
Unknown Facility
Verona, 37126, Italy
Related Publications (2)
Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
PMID: 16908937RESULTAbou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4.
PMID: 21673874RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Subjects had advanced disease and were heavily pretreated. National Cancer Institute-Common Toxicity Criteria (NCI-CTC) was translated to Medical Dictionary for Regulatory Activities (MedDRA) for System Organ Class (SOC) only.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2002
First Posted
September 4, 2002
Study Start
August 1, 2002
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 16, 2014
Results First Posted
August 6, 2009
Record last verified: 2014-03