Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034177
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2002-04-23
Brief Title:
Safety and Efficacy of S-8184 in Treatment of Locally Advanced Metastatic or Recurrent TCC of the Urothelium
Sponsor:
Achieve Life Sciences
Organization:
Achieve Life Sciences
Study Overview
Official Title:
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
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None