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Sponsors and Collaborators: |
Massachusetts General Hospital Department of Defense |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00299741 |
This study is directed at two populations of men with advanced prostate cancer:
Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are:
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of SU011248 in Men With Advanced Prostate Cancer |
Enrollment: | 34 |
Study Start Date: | March 2006 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Experimental
Sunitinib
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Drug: Sunitinib
Sunitinib 50 mg daily, 4/2 schedule
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow reserve:
Adequate hepatic function:
For Group A only:
· No prior treatment for prostate cancer with cytotoxic chemotherapy
For Group B only:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel-Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Dror Michaelson, MD PhD | Massachusetts General Hospital |
Study ID Numbers: | W81XWH-05-1-0439 |
Study First Received: | March 3, 2006 |
Last Updated: | November 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00299741 |
Health Authority: | United States: Food and Drug Administration |
Sutent Sunitinib Bone |
Metastatic Hormone-refractory Biomarkers |
Prostatic Diseases Genital Neoplasms, Male Sunitinib |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |