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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00664326 |
This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY 73-4506 to evaluate the response rate of BAY 73-4506 in previously untreated patients with metastatic or unresectable Renal Cell Cancer (RCC).
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: BAY 73-4506 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Uncontrolled Study of BAY 73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer ( RCC) |
Estimated Enrollment: | 52 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: BAY 73-4506
Patients will be treated with BAY 73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY 73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.
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The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterward.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Los Angeles, California, United States, 90089 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
Finland | |
Helsinki, Finland, 00290 | |
Turku, Finland, 20520 | |
France | |
PARIS, France, 75674 | |
NANTES, France, 44020 | |
Germany | |
Berlin, Germany, 10967 | |
Hamburg, Germany, 20251 | |
Germany, Hessen | |
Frankfurt, Hessen, Germany, 60596 | |
Germany, Sachsen | |
Dresden, Sachsen, Germany, 01307 | |
Poland | |
Poznan, Poland, 60-355 | |
Lublin, Poland, 20-090 | |
Bialystok, Poland, 15-027 | |
United Kingdom, Avon | |
Bristol, Avon, United Kingdom, BS2 8ED | |
United Kingdom, Cambridgeshire | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
United Kingdom, Greater London | |
London, Greater London, United Kingdom, SE1 9RT | |
United Kingdom, Leicestershire | |
Leicester, Leicestershire, United Kingdom, LE1 5WW | |
United Kingdom, Middlesex | |
Northwood, Middlesex, United Kingdom, HA6 2RN |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals Inc ( Health Clinical Pharmacology ) |
Study ID Numbers: | 11726, EudraCT: 2008-000107-28 |
Study First Received: | April 17, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00664326 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Renal Cell Carcinoma |
Disulfiram Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |