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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00108953 |
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).
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Hepatocellular |
Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Drug: Doxorubicin/Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Study of BAY 43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma. |
Enrollment: | 96 |
Study Start Date: | April 2005 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Multi kinase inhibitor plus Chemotherapy
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Arm 2: Active Comparator |
Drug: Doxorubicin/Placebo
Chemotherapy plus Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 11546, EudraCT 2004-001770-40 |
Study First Received: | April 21, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00108953 |
Health Authority: | United States: Food and Drug Administration |
Cancer Liver Cancer Hepatocellular carcinoma HCC |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Doxorubicin Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antibiotics, Antineoplastic Protein Kinase Inhibitors Pharmacologic Actions |