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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956436
First Posted: August 11, 2009
Last Update Posted: September 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  Purpose
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: None (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
IV Q3W
Other Names:
  • IGF-1R
  • Liver Cancer
  • Hepatocellular Carcinoma
  • Monoclonal Antibody
  • Sorafenib
  • HCC
  • Nexavar

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956436


Locations
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
Singapore
Resesarch Site
Singapore, Singapore
Taiwan
Resesarch Site
Tainan, Taiwan
Resesarch Site
Taipei, Taiwan
Resesarch Site
Tao-Yuan, Taiwan
United Kingdom
Resesarch Site
Edgbaston, Birmingham, United Kingdom
Sponsors and Collaborators
Biogen
  More Information

Responsible Party: Terri Senta-McMillian, PRA, Int'l
ClinicalTrials.gov Identifier: NCT00956436     History of Changes
Other Study ID Numbers: 212HC201
First Submitted: August 5, 2009
First Posted: August 11, 2009
Last Update Posted: September 16, 2013
Last Verified: November 2011

Keywords provided by Biogen:
Liver Cancer
Hepatocellular Carcinoma
Sorafenib
HCC
BIIB022
Open-Label
IGF-1R
Nexavar

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Sorafenib
Niacinamide
Mecasermin
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances