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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)

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.
 
ClinicalTrials.gov Identifier: NCT00956436
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : September 16, 2013
Sponsor:
Information provided by:
Biogen

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: BIIB022 Drug: Sorafenib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To evaluate the PK profile of BIIB022 and sorafenib in this study population [ Time Frame: 6 months ]
  2. To assess the anti-tumor response in this study population [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Colorado
Resesarch Site
Denver, Colorado, United States
United States, Florida
Resesarch Site
Ocoee, Florida, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Massachusetts
Resesarch Site
Boston, Massachusetts, United States
United States, New York
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New York, New York, United States
United States, Virginia
Resesarch Site
Norfolk, Virginia, United States
Singapore
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Singapore, Singapore
Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
Resesarch Site
Tao-Yuan, Taiwan
United Kingdom
Resesarch Site
Edgbaston, Birmingham, United Kingdom
Sponsors and Collaborators
Biogen
More Information
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Responsible Party: Terri Senta-McMillian, PRA, Int'l
ClinicalTrials.gov Identifier: NCT00956436    
Other Study ID Numbers: 212HC201
First Posted: August 11, 2009    Key Record Dates
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:
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Sorafenib
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
 Antineoplastic Agents, Immunological
Liver Extracts
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics