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| Sponsored by: |
OncoGenex Pharmaceuticals |
|---|---|
| Information provided by: | OncoGenex 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 |
| 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 | |
More Information
| Study ID Numbers: | SON-8184-1073 |
| Study First Received: | February 10, 2004 |
| Last Updated: | June 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077688 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Urinary Tract Neoplasm Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Antimitotic Agents Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma |
Urologic Diseases Paclitaxel Tubulin Modulators Urethral Neoplasms Bladder Neoplasm Antineoplastic Agents, Phytogenic Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Antimitotic Agents Carcinoma, Transitional Cell Urologic Neoplasms Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Urologic Diseases Paclitaxel Therapeutic Uses Tubulin Modulators Urethral Neoplasms Urethral Diseases Antineoplastic Agents, Phytogenic Ureteral Neoplasms Neoplasms, Glandular and Epithelial |