Hepatocellular Carcinoma
Conditions
Keywords
Liver Cancer, Hepatocellular Carcinoma, Sorafenib, HCC, BIIB022, Open-Label, IGF-1R, Nexavar
Brief summary
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.
Interventions
DRUGBIIB022
IV Q3W
DRUGSorafenib
Standard dosing of Sorafenib
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK profile of BIIB022 and sorafenib in this study population | 6 months |
| To assess the anti-tumor response in this study population | 6 months |
Countries
Singapore, Taiwan, United Kingdom, United States
Outcome results
None listed