Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Biogen

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Drug: BIIB022

Study type: Interventional

Funder types: Industry

Identifiers

NCT00956436

212HC201

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sorafenib Monotherapy

Experimental group

Description:

Sorafenib Monotherapy

Treatment:

Drug: Sorafenib

Sorafenib with BIIB022

Experimental group

Description:

Sorafenib with BIIB022

Treatment:

Drug: BIIB022