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| Sponsored by: |
Sonus Pharmaceuticals |
| Information provided by: | Sonus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00077688 |
Purpose
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
| Condition | Intervention | Phase |
|
Bladder Neoplasms Ureteral Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell |
Drug: TOCOSOL Paclitaxel |
Phase II |
| Genetics Home Reference related topics: | bladder cancer |
| MedlinePlus related topics: | Bladder Cancer Cancer |
| ChemIDplus related topics: | Paclitaxel |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(TM) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) in Patients With Metastatic or Locally Advanced, Unresectable Transitional Cell Carcinoma of the Urothelium |
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, Maryland | |||||
| University of Maryland Medical Center/Greenbaum Cancer Center | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| United States, Ohio | |||||
| Cleveland Clinic Foundation | |||||
| Cleveland, Ohio, United States, 44195 | |||||
| United States, Washington | |||||
| University of Washington/Seattle Cancer Care Alliance | |||||
| Seattle, Washington, United States, 98109 | |||||
| Sonus Pharmaceuticals |
More Information
| Study ID Numbers: | SON-8184-1073 |
| First Received: | February 10, 2004 |
| Last Updated: | October 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00077688 |
| Health Authority: | United States: Food and Drug Administration |
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