Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00956436
First received: August 5, 2009
Last updated: June 7, 2012
Last verified: November 2011
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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 Endpoint Classification: Safety/Efficacy Study 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:
Drug Information available for:
Insulin-like growth factor I
Sorafenib
Sorafenib tosylate
Mecasermin rinfabate
U.S. FDA Resources
Further study details as provided by Biogen Idec:
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the PK profile of BIIB022 and sorafenib in this study population [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To assess the anti-tumor response in this study population [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| 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:
|
|
Experimental: Sorafenib with BIIB022
Sorafenib with BIIB022
|
Drug: BIIB022
IV Q3W
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Idec
More Information
Additional Information:
No publications provided
| Responsible Party: | Terri Senta-McMillian, PRA, Int'l |
| ClinicalTrials.gov Identifier: | NCT00956436 History of Changes |
| Other Study ID Numbers: | 212HC201 |
| Study First Received: | August 5, 2009 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
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 Antibodies, Monoclonal Sorafenib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013