Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Liver Extracts; Niacinamide; Sorafenib

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