Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

Completed · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT00956436

Run by

Biogen

People needed

40

Starts

2009-08-01

Expected to finish

2011-04-01

Last updated by the study team

2013-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Resesarch Site — Denver, Colorado, United States
• Resesarch Site — Ocoee, Florida, United States
• Resesarch Site — Indianapolis, Indiana, United States
• Resesarch Site — Boston, Massachusetts, United States
• Resesarch Site — New York, New York, United States
• Resesarch Site — Norfolk, Virginia, United States
• Resesarch Site — Singapore, Singapore
• Resesarch Site — Tainan, Taiwan
• Resesarch Site — Taipei, Taiwan
• Resesarch Site — Taoyuan, Taiwan
• Resesarch Site — Edgbaston, Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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