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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00044564 |
In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: Bay 59-8862 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Scripps Clinic & Research Foundation | |
La Jolla, California, United States, 92037 | |
United States, Indiana | |
Medical Consultants, PC | |
Muncie, Indiana, United States, 47304 | |
United States, Louisiana | |
Ochsner Foundation Hospital | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
University of Maryland Hospital Sys. | |
Baltimore, Maryland, United States, 21201-1595 | |
Urology Associates | |
Greenbelt, Maryland, United States, 20770 | |
United States, Michigan | |
Providence Hospital | |
Southfield, Michigan, United States, 48075 | |
Harper Hospital | |
Detroit, Michigan, United States, 48201-9027 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 630 | |
St Louis University HSC | |
St. Louis, Missouri, United States, 63104 | |
United States, Montana | |
Billings Oncology Associates | |
Billings, Montana, United States, 59101 | |
United States, New Jersey | |
Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08901 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study ID Numbers: | Protocol No. 100386 |
Study First Received: | August 30, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00044564 |
Health Authority: | United States: Food and Drug Administration |
Taxane, Renal Cell Carcinoma Advanced Renal Cell Carcinoma |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Taxane Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |