A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
212HC201
NCT ID:
NCT00956436
Start Date:
August 2009
Completion Date:
April 2011
Related Keywords:
- Hepatocellular Carcinoma
- Liver Cancer
- Hepatocellular Carcinoma
- Sorafenib
- HCC
- BIIB022
- Open-Label
- IGF-1R
- Nexavar
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Resesarch Site | Denver, Colorado |
| Resesarch Site | Ocoee, Florida |
| Resesarch Site | Indianapolis, Indiana |
| Resesarch Site | Boston, Massachusetts |
| Resesarch Site | New York, New York |
| Resesarch Site | Norfolk, Virginia |
