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| Sponsor: | University of Michigan Cancer Center |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by (Responsible Party): | Maha Hussain, M.D., University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00393796 |
Purpose
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: SUTENT |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma |
| Enrollment: | 55 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
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Drug: SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Other Name: SU011248
|
|
Placebo Comparator: 2
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
Drug: SUTENT
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Other Name: SU011248
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| David Geffen School of Medicine at UCLA | |
| Los Angeles, California, United States, 90095 | |
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic - Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Maha H. Hussain, M.D. | University of Michigan Cancer Center |
More Information
| Responsible Party: | Maha Hussain, M.D., Professor of Internal Medicine, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00393796 History of Changes |
| Other Study ID Numbers: | UMCC 2005.145 |
| Study First Received: | October 27, 2006 |
| Last Updated: | December 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |