Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Phase 1CompletedNCT00956436

Biogen40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

BIIB022DRUG

IV Q3W

SorafenibDRUG

Standard dosing of Sorafenib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Resesarch Site

Denver, Colorado, United States

Resesarch Site

Ocoee, Florida, United States

Resesarch Site

Indianapolis, Indiana, United States

Resesarch Site

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.

Time frame: 6 months

Secondary Outcomes

To evaluate the PK profile of BIIB022 and sorafenib in this study population

Time frame: 6 months

To assess the anti-tumor response in this study population

Time frame: 6 months

Data from ClinicalTrials.gov

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