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| Sponsor: | Bayer |
|---|---|
| Collaborator: |
ICON Clinical Research |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00625378 |
Purpose
This study is focusing on patients with cancer who are currently enrolled in a Bayer/Onyx sponsored clinical trial and receive sorafenib as monotherapy or concurrent combination of sorafenib with TACE (transarterial chemoembolization). During the entire course of the study, which is about 5 years, numerous patients will be treated with sorafenib. Involvement in this study will be depending on whether the patient benefits from the treatment or not, based on the physician's judgment and the results of particular additional examinations. Overall, participation in this study will help to evaluate the safety of treatment with sorafenib.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: Sorafenib (Nexavar, BAY43-9006) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sorafenib Long Term Extension Program |
| Estimated Enrollment: | 1000 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Sorafenib (Nexavar, BAY43-9006)
All patients are treated with sorafenib according to the dosage scheme of their previous trial.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Excluded therapies and medications, previous and concomitant:
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 76 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00625378 History of Changes |
| Other Study ID Numbers: | 12311, 2007-002604-17 |
| Study First Received: | February 20, 2008 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Cancer Institute New South Wales Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Commission d'Ethique Biomedicale Hospitalo-Facultaire Brazil: Hosptial Das Clinicas - FMUS Brazil: National Health Surveillance Agency Canada: Health Canada France: Afssaps - French Health Products Safety Agency France: Comite de Protection des personnes - Sud-Ouest et Outre Mer III Germany: Ethics Commission - Universitatsklinikum Essen Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency New Zealand: Health and Disability Ethics Committees New Zealand: Medsafe Poland: Ministry of Health Russia: Ethics Committee Russia: Ministry of Health and Social Development of the Russian Federation Russia: Scientific Centre of Expertise of Medical Remedies Spain: Ethics Committee Spain: Spanish Agency of Medicines Taiwan: Department of Health Taiwan: National Taiwan University Hospital Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Research Ethics Service South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) United States: Institutional Review Board China: State Food and Drug Administration China: Ministry of Health United States: Food and Drug Administration |
|
Cancer Sorafenib Extension program |
|
Neoplasms Sorafenib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |