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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00622479 |
The purpose of this study is to:
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: Sorafenib (Nexavar, BAY43-9006) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mechanistic Evaluations on Sorafenib Induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib will be administered at 400mg BID for a 28 day cycle.
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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:
Patients who meet the following criteria at the time of screening will be excluded:
combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints
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 |
United States, Arizona | |
Terminated | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
Recruiting | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Recruiting | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Not yet recruiting | |
Stony Brook, New York, United States, 11794 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals Inc. ( Head Clinical Pharmacology ) |
Study ID Numbers: | 12345 |
Study First Received: | February 13, 2008 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00622479 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sorafenib Hypophosphatemia Left ventricular ejection fraction (LVEF) Beta-type Natriuretic Peptide (BNP) |
Urinary Tract Neoplasm Kidney Cancer Metabolic Diseases Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Carcinoma Renal Cancer Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Hypophosphatemia Kidney Diseases Adenocarcinoma Sorafenib Metabolic Disorder Neoplasms, Glandular and Epithelial |
Phosphorus Metabolism Disorders Metabolic Diseases 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 Hypophosphatemia Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |