Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-03 @ 3:12 AM
Study NCT ID:
NCT00034151
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2002-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer
Sponsor:
Achieve Life Sciences
Organization:
Study Overview
Official Title:
A Phase IIA Evaluation of Safety and Efficacy of Weekly S-8184 Paclitaxel Injectable Emulsion in Second Line Treatment of Stage III or IV Platinum Resistant Ovarian Cancer or Primary Peritoneal Carcinoma
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 with stage III or IV platinum resistant ovarian cancer or primary peritoneal carcinoma.
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: