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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00077974 |
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: SU011248 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma |
Enrollment: | 106 |
Study Start Date: | February 2004 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: SU011248
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
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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:
United States, California | |
Pfizer Investigational Site | |
San Francisco, California, United States, 94115 | |
Pfizer Investigational Site | |
Duarte, California, United States, 91010-3000 | |
Pfizer Investigational Site | |
Pasadena, California, United States, 91105 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02114 | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
Pfizer Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Pfizer Investigational Site | |
ANN ARBOR, Michigan, United States, 48109 | |
United States, Minnesota | |
Pfizer Investigational Site | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Pfizer Investigational Site | |
NEW YORK, New York, United States, 10021 | |
Pfizer Investigational Site | |
New York, New York, United States, 10022 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Pfizer Investigational Site | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Pfizer Investigational Site | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Wisconsin | |
Pfizer Investigational Site | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181006 |
Study First Received: | February 13, 2004 |
Last Updated: | July 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00077974 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Sunitinib Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site |
Urologic Diseases Kidney Neoplasms Sunitinib Therapeutic Uses Carcinoma, Renal Cell Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |