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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

This study has been completed.
Information provided by:
Biogen Identifier:
First received: August 5, 2009
Last updated: September 12, 2013
Last verified: November 2011
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Condition Intervention Phase
Hepatocellular Carcinoma
Drug: BIIB022
Drug: Sorafenib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib Monotherapy
Sorafenib Monotherapy
Drug: Sorafenib
Standard dosing of Sorafenib
Other Names:
  • HCC
  • Monoclonal Antibody
  • Hepatocellular Carcinoma
  • Liver Cancer
  • BIIB022
  • IGF-1R
  • Nexavar
Experimental: Sorafenib with BIIB022
Sorafenib with BIIB022
Drug: BIIB022
Other Names:
  • IGF-1R
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Monoclonal Antibody
  • Sorafenib
  • HCC
  • Nexavar


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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/exclusion criteria may apply

  Contacts and Locations
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Please refer to this study by its identifier: NCT00956436

United States, Colorado
Resesarch Site
Denver, Colorado, United States
United States, Florida
Resesarch Site
Ocoee, Florida, United States
United States, Indiana
Resesarch Site
Indianapolis, Indiana, United States
United States, Massachusetts
Resesarch Site
Boston, Massachusetts, United States
United States, New York
Resesarch Site
New York, New York, United States
United States, Virginia
Resesarch Site
Norfolk, Virginia, United States
Resesarch Site
Singapore, Singapore
Resesarch Site
Tainan, Taiwan
Resesarch Site
Taipei, Taiwan
Resesarch Site
Tao-Yuan, Taiwan
United Kingdom
Resesarch Site
Edgbaston, Birmingham, United Kingdom
Sponsors and Collaborators
  More Information

Responsible Party: Terri Senta-McMillian, PRA, Int'l Identifier: NCT00956436     History of Changes
Other Study ID Numbers: 212HC201
Study First Received: August 5, 2009
Last Updated: September 12, 2013

Keywords provided by Biogen:
Liver Cancer
Hepatocellular Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances processed this record on March 28, 2017