Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
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ClinicalTrials.gov Identifier: NCT00956436 |
Recruitment Status :
Completed
First Posted : August 11, 2009
Last Update Posted : September 16, 2013
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma | Drug: BIIB022 Drug: Sorafenib | Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Sorafenib Monotherapy
Sorafenib Monotherapy
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Drug: Sorafenib
Standard dosing of Sorafenib
Other Names:
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Experimental: Sorafenib with BIIB022
Sorafenib with BIIB022
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Drug: BIIB022
IV Q3W
Other Names:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
United States, Colorado | |
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Denver, Colorado, United States | |
United States, Florida | |
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Ocoee, Florida, United States | |
United States, Indiana | |
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Indianapolis, Indiana, United States | |
United States, Massachusetts | |
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Boston, Massachusetts, United States | |
United States, New York | |
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New York, New York, United States | |
United States, Virginia | |
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Norfolk, Virginia, United States | |
Singapore | |
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Singapore, Singapore | |
Taiwan | |
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Tainan, Taiwan | |
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Taipei, Taiwan | |
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Tao-Yuan, Taiwan | |
United Kingdom | |
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Edgbaston, Birmingham, United Kingdom |
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 |
Liver Cancer Hepatocellular Carcinoma Sorafenib HCC |
BIIB022 Open-Label IGF-1R Nexavar |
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 |