Back to resultsA Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Cancer, Liver Cancer, Hepatocellular carcinoma (HCC)
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Fibrolamellar disease mixed histology Metastatic brain or meningeal tumors
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sorafenib 400 mg b.i.d.
Arm Description
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of Response
Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
Time to Response
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
Time to Progression
Time from the first date of receiving study drug until the first documented PD.
Duration of Stable Disease
Time from the first day of receiving study drug until there was a documented PD or response.
Time to Minor Response
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
Duration of Minor Response
Time from the date that MR was first documented to the date that PD was first documented.
Overall Survival
Time from the first date of receiving study medication to death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044512
Brief Title
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Official Title
A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
Pharmacokinetics (PK) profile of Sorafenib
Plasma and tissue tumor biomarkers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Cancer, Liver Cancer, Hepatocellular carcinoma (HCC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib 400 mg b.i.d.
Arm Type
Experimental
Arm Description
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Primary Outcome Measure Information:
Title
Percentage of Participants for Each Type of Response
Description
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.
Time Frame
Until 30 days after termination of active therapy
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.
Time Frame
up to 3 years later
Title
Time to Response
Description
Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).
Time Frame
up to 3 years later
Title
Time to Progression
Description
Time from the first date of receiving study drug until the first documented PD.
Time Frame
up to 3 years later
Title
Duration of Stable Disease
Description
Time from the first day of receiving study drug until there was a documented PD or response.
Time Frame
up to 3 years later
Title
Time to Minor Response
Description
Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.
Time Frame
up to 3 years later
Title
Duration of Minor Response
Description
Time from the date that MR was first documented to the date that PD was first documented.
Time Frame
Time from MR to PD
Title
Overall Survival
Description
Time from the first date of receiving study medication to death.
Time Frame
Start of treatment to death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Fibrolamellar disease mixed histology
Metastatic brain or meningeal tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021-6007
Country
United States
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1090
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
City
Marseille
ZIP/Postal Code
13005
Country
France
City
Paris
ZIP/Postal Code
75020
Country
France
City
Rennes Cedex
ZIP/Postal Code
35062
Country
France
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
City
Forlì
ZIP/Postal Code
47100
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Verona
ZIP/Postal Code
37126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16908937
Citation
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.
Results Reference
result
PubMed Identifier
21673874
Citation
Abou-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.
Results Reference
result
Learn more about this trial
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
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