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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00855218 |
This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Hepatocellular Carcinoma |
Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC). |
Estimated Enrollment: | 350 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d., 2 tablets)TACE using DC Bead.
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Arm 2: Placebo Comparator |
Drug: Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d.)
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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:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12918, EudraCT: 2008-005056-24 |
Study First Received: | March 3, 2009 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00855218 History of Changes |
Health Authority: | Austria: Ethikkommission; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Institutional Review Board; Canada: Health Canada; China: Ministry of Health; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Spain: Ministry of Health; Taiwan: Institutional Review Board; United States: Food and Drug Administration; Singapore: Health Sciences Authority; Korea: Food and Drug Administration; United States: Food and Drug Administration |
Sorafenib TACE DC bead Combination |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Protein Kinase Inhibitors Doxorubicin Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |