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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 October 2017 |
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Main ID: |
NCT00044512 |
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Date of registration:
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30/08/2002 |
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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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A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
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Scientific title:
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A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma |
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Date of first enrolment:
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August 2002 |
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Target sample size:
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137 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00044512 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Israel
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Italy
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United States
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
- Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
- Measurable disease
- At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography
(CT) scan or magnetic resonance imaging (MRI)
- Presence of at least 1 of the following:
- Alpha-fetoprotein greater than the upper limit of normal (ULN)
- Hepatitis C antibody positive
- Hepatitis B surface antigen positive
- Child's Pugh class A or B
- Candidate for systemic therapy
Exclusion Criteria:
- Fibrolamellar disease mixed histology
- Metastatic brain or meningeal tumors
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Carcinoma, Hepatocellular
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Intervention(s)
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Drug: Sorafenib (Nexavar, BAY43-9006)
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Primary Outcome(s)
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Percentage of Participants for Each Type of Response
[Time Frame: Until 30 days after termination of active therapy]
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Secondary Outcome(s)
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Time to Response
[Time Frame: up to 3 years later]
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Duration of Response
[Time Frame: up to 3 years later]
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Duration of Minor Response
[Time Frame: Time from MR to PD]
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Overall Survival
[Time Frame: Start of treatment to death]
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Time to Minor Response
[Time Frame: up to 3 years later]
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Duration of Stable Disease
[Time Frame: up to 3 years later]
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Time to Progression
[Time Frame: up to 3 years later]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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