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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00492752 |
Purpose
The purpose of the study is
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-blinded, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
| Enrollment: | 226 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Nexavar (Sorafenib, BAY43-9006)
multikinase inhibitor; sorafenib 400 mg (orally) twice daily
|
| Arm 2: Placebo Comparator |
Drug: Placebo
Matching placebo (orally) twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have at least one tumor lesion that meets both of the following criteria
Exclusion Criteria:
Contacts and Locations| China | |
| Beijing, China, 100021 | |
| Beijing, China, 100039 | |
| Tianjin, China | |
| Chongqing, China, 400038 | |
| Shanghai, China, 200003 | |
| Shanghai, China, 200032 | |
| China, Anhuii | |
| Hefei, Anhuii, China, 230022 | |
| China, Guangdong | |
| Guangzhou, Guangdong, China, 510060 | |
| Guangzhou, Guangdong, China, 510515 | |
| China, Hubei | |
| Wuhan, Hubei, China, 430030 | |
| China, Jiangsu | |
| Nanjing, Jiangsu, China, 210002 | |
| Nanjing, Jiangsu, China, 210009 | |
| China, Liaoning | |
| Dalian, Liaoning, China, 116011 | |
| Dalian, Liaoning, China, 116027 | |
| China, Zhejiang | |
| Hangzhou, Zhejiang, China, 310016 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 138-736 | |
| Seoul, Korea, Republic of, 152-703 | |
| Daegu, Korea, Republic of, 702-701 | |
| Taiwan | |
| Taipei, Taiwan, 100 | |
| Taoyuan, Taiwan, 333 | |
| Taipei, Taiwan, 112 | |
| Changhua, Taiwan, 500 | |
| Tainan, Taiwan, 736 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 11849 |
| Study First Received: | June 26, 2007 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00492752 History of Changes |
| Health Authority: | Taiwan: National Bureau of Controlled Drugs; China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA) |
|
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 |