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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00956436 |
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Date of registration:
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05/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
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Scientific title:
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A Phase 1b, Open-Label Study of Sorafenib With BIIB022 in Subjects With Advanced Hepatocellular Carcinoma |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00956436 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Taiwan
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: BIIB022
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Drug: Sorafenib
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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To assess the anti-tumor response in this study population
[Time Frame: 6 months]
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To evaluate the PK profile of BIIB022 and sorafenib in this study population
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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