Trials / Completed
CompletedNCT00034177
Safety and Efficacy of S-8184 in Treatment of Locally Advanced, Metastatic, or Recurrent TCC of the Urothelium
Safety And Efficacy Of Weekly Administration Of S-8184 Paclitaxel Injectable Emulsion In Second Line Treatment Of Patients With Locally Advanced, Metastatic, Or Recurrent Transitional Cell Carcinoma Of The Urothelium
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S-8184 Paclitaxel Injectable Emulsion | |
| DRUG | Experimental Arm: TOCOSOL Paclitaxel | Doses of 80, 100 and 120mg/m2 |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2007-09-01
- Completion
- 2007-09-01
- First posted
- 2002-04-25
- Last updated
- 2009-06-04
Source: ClinicalTrials.gov record NCT00034177. Inclusion in this directory is not an endorsement.