Status:
COMPLETED
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Biogen
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00956436
Start Date
August 1 2009
End Date
April 1 2011
Last Update
September 16 2013
Active Locations (11)
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1
Resesarch Site
Denver, Colorado, United States
2
Resesarch Site
Ocoee, Florida, United States
3
Resesarch Site
Indianapolis, Indiana, United States
4
Resesarch Site
Boston, Massachusetts, United States