Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
NCT00034177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2009-06-04
Summary
Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients locally advanced, metastatic, or recurrent transitional cell carcinoma of the urothelium.
Conditions
- Urologic Neoplasms
Interventions
- DRUG
-
S-8184 Paclitaxel Injectable Emulsion
- DRUG
-
Experimental Arm: TOCOSOL Paclitaxel
Doses of 80, 100 and 120mg/m2
Sponsors & Collaborators
-
Achieve Life Sciences
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-04-30
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
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