Back to resultsSorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BIIB022
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R, Nexavar
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
- Child-Pugh score A5 or A6.
- ECOG Performance Status of ≤2.
Exclusion Criteria:
- Known central nervous system or brain metastases.
- Prior anti-IGF-1R therapy.
- Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
- Concurrent anticancer therapy.
- History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
- Acute hepatitis
- Fibrolamellar HCC
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Resesarch Site
- Resesarch Site
- Resesarch Site
- Resesarch Site
- Resesarch Site
- Resesarch Site
- Resesarch Site
- Resesarch Site
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- Resesarch Site
- Resesarch Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sorafenib Monotherapy
Sorafenib with BIIB022
Arm Description
Sorafenib Monotherapy
Sorafenib with BIIB022
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Secondary Outcome Measures
To evaluate the PK profile of BIIB022 and sorafenib in this study population
To assess the anti-tumor response in this study population
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956436
Brief Title
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Official Title
A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R, Nexavar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib Monotherapy
Arm Type
Experimental
Arm Description
Sorafenib Monotherapy
Arm Title
Sorafenib with BIIB022
Arm Type
Experimental
Arm Description
Sorafenib with BIIB022
Intervention Type
Drug
Intervention Name(s)
BIIB022
Other Intervention Name(s)
IGF-1R, Liver Cancer, Hepatocellular Carcinoma, Monoclonal Antibody, Sorafenib, HCC, Nexavar
Intervention Description
IV Q3W
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
HCC, Monoclonal Antibody, Hepatocellular Carcinoma, Liver Cancer, BIIB022, IGF-1R, Nexavar
Intervention Description
Standard dosing of Sorafenib
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To evaluate the PK profile of BIIB022 and sorafenib in this study population
Time Frame
6 months
Title
To assess the anti-tumor response in this study population
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST.
Child-Pugh score A5 or A6.
ECOG Performance Status of ≤2.
Exclusion Criteria:
Known central nervous system or brain metastases.
Prior anti-IGF-1R therapy.
Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if subjects have documented disease progression according to modified RECIST.
Concurrent anticancer therapy.
History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
Acute hepatitis
Fibrolamellar HCC
Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Resesarch Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Resesarch Site
City
Ocoee
State/Province
Florida
Country
United States
Facility Name
Resesarch Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Resesarch Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Resesarch Site
City
New York
State/Province
New York
Country
United States
Facility Name
Resesarch Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Resesarch Site
City
Singapore
Country
Singapore
Facility Name
Resesarch Site
City
Tainan
Country
Taiwan
Facility Name
Resesarch Site
City
Taipei
Country
Taiwan
Facility Name
Resesarch Site
City
Tao-Yuan
Country
Taiwan
Facility Name
Resesarch Site
City
Edgbaston
State/Province
Birmingham
Country
United Kingdom
12. IPD Sharing Statement
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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
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