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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00771147 |
Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.
Condition | Intervention | Phase |
---|---|---|
Advanced Renal Cell Carcinoma ( RCC) |
Drug: Nexavar (Sorafenib, BAY43-9006) |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prospective Open-Label Non-Interventional, Non-Controlled Multi Observational and Pharmaco-Economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-Life Treatment Conditions |
n.a.
Estimated Enrollment: | 125 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Arm 1 |
Drug: Nexavar (Sorafenib, BAY43-9006)
Patients with diagnosis of advanced renal cell cancer and decision taken by the investigator to prescribe Nexavar®.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with diagnosis of advanced Renal Cell Carcimona
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Belgium | |
Recruiting | |
GENT, Belgium, 9000 | |
Recruiting | |
ANTWERPEN, Belgium, 2020 | |
Not yet recruiting | |
BRUXELLES - BRUSSEL, Belgium, 1200 | |
Recruiting | |
BRASSCHAAT, Belgium, 2930 | |
Recruiting | |
TURNHOUT, Belgium, 2300 | |
Recruiting | |
BRUGGE, Belgium, 8000 | |
Recruiting | |
BONHEIDEN, Belgium, 2820 | |
Not yet recruiting | |
MERKSEM, Belgium, 2170 | |
Recruiting | |
AALST, Belgium, 9300 | |
Recruiting | |
ROESELARE, Belgium, 8800 | |
Recruiting | |
LA LOUVIERE, Belgium, 7100 | |
Recruiting | |
LIEGE, Belgium, 4000 | |
Not yet recruiting | |
ANTWERPEN, Belgium, 2060 | |
Not yet recruiting | |
CHIMAY, Belgium, 6460 | |
Recruiting | |
OOSTENDE, Belgium, 8400 | |
Not yet recruiting | |
OOSTENDE, Belgium, 8400 | |
Not yet recruiting | |
BRUXELLES - BRUSSEL, Belgium, 1070 | |
Not yet recruiting | |
YVOIR, Belgium, 5530 | |
Recruiting | |
ARLON, Belgium, 6700 | |
Recruiting | |
DENDERMONDE, Belgium, 9200 | |
Not yet recruiting | |
BRAINE-L'ALLEUD, Belgium, 1420 | |
Not yet recruiting | |
HUY, Belgium, 4500 | |
Not yet recruiting | |
BRUXELLES - BRUSSEL, Belgium, 1000 | |
Recruiting | |
BRUXELLES - BRUSSEL, Belgium, 1070 | |
Not yet recruiting | |
EDEGEM, Belgium, 2650 | |
Not yet recruiting | |
BOUGE, Belgium, 5004 | |
Recruiting | |
IEPER, Belgium, 8900 | |
Not yet recruiting | |
GILLY, Belgium, 6060 | |
Not yet recruiting | |
CHARLEROI, Belgium, 6000 | |
Terminated | |
GEEL, Belgium, 2440 | |
Not yet recruiting | |
KORTRIJK, Belgium, 8500 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 13102 |
Study First Received: | October 9, 2008 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00771147 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |