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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: Nexavar (Sorafenib, 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 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1
n/a
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Drug: Nexavar (Sorafenib, 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:
Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Exclusion Criteria:
Patients who meet the following criteria at the time of screening will be excluded:
Contact: Bayer Clinical Trial Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+) 1-888-842-2937 |
United States, Arizona | |
Not yet recruiting | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, Florida | |
Not yet recruiting | |
Jacksonville, Florida, United States, 32224 | |
United States, Minnesota | |
Recruiting | |
Rochester, Minnesota, United States, 55905 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12345 |
Study First Received: | February 13, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00622479 |
Health Authority: | United States: Food and Drug Administration |
Sorafenib Hypophosphatemia Left ventricular ejection fraction (LVEF) Beta-type Natriuretic Peptide (BNP) |
Metabolic Diseases Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Carcinoma, Renal Cell Hypophosphatemia Kidney Diseases Metabolic disorder Adenocarcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Phosphorus Metabolism Disorders Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |