Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT01332656
Status:
COMPLETED
Last Update Posted:
2015-12-21
First Post:
2011-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase 2, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
Status:
COMPLETED
Status Verified Date:
2015-11
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:
OPSALIN
Brief Summary:
Primary Objective:
\- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.
Secondary Objectives:
* To compare the overall survival (OS) between the 2 treatment arms
* To compare the objective response rate (RR) between the 2 treatment arms
\- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin.
Secondary Objectives:
* To compare the overall survival (OS) between the 2 treatment arms
* To compare the objective response rate (RR) between the 2 treatment arms
Detailed Description:
Treatment will continue until disease progression or unacceptable toxicity or consent withdrawal. A minimum of 6 cycles of the combined therapies should be administered, unless progression occurs before or safety reasons cause the discontinuation of one or two drugs of the combination therapies. In case of no progression, it will be investigator's decision to continue or not the study treatment after 6 cycles according to his clinical practice.
Study Oversight
Has Oversight DMC:
False
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?: