A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00108953 |
Recruitment Status :
Completed
First Posted : April 22, 2005
Results First Posted : June 11, 2009
Last Update Posted : October 31, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | April 21, 2005 | |||
First Posted Date ICMJE | April 22, 2005 | |||
Results First Submitted Date ICMJE | April 23, 2009 | |||
Results First Posted Date ICMJE | June 11, 2009 | |||
Last Update Posted Date | October 31, 2014 | |||
Study Start Date ICMJE | April 2005 | |||
Actual Primary Completion Date | April 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Time to Progression (TTP) [ Time Frame: from date of randomization of the first patient until 3 years later ] TTP was defined as the time from randomization to radiological disease progression by independent assessment.
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma | |||
Official Title ICMJE | A Randomized Controlled Study of BAY43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma. | |||
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC). | |||
Detailed Description | In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations. The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints. The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Hepatocellular | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
96 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | April 2008 | |||
Actual Primary Completion Date | April 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Canada, Hong Kong, Russian Federation, United Kingdom, United States | |||
Removed Location Countries | China | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00108953 | |||
Other Study ID Numbers ICMJE | 11546 2004-001770-40 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |