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| Sponsored by: |
Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00692770 |
Purpose
To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III Randomized, Double-Blind, Placebo-Controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation. |
| Estimated Enrollment: | 1100 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
|
| Arm 2: Placebo Comparator |
Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
Show 212 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 12414, 2008-001087-36, STORM |
| Study First Received: | June 5, 2008 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00692770 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatocellular, Sorafenib, Adjuvant, Surgical resection, Ablation |
|
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Adjuvants, Immunologic Protein Kinase Inhibitors Recurrence 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 |