Ovarian Cancer Recurrent Clinical Trial
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
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
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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