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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:solution Route of administration: intravenous
Progression Free Survival (PFS)
Time frame: approximately 24 months
Overall Survival (OS)
Time frame: approximately 24 months
Objective Response Rate (RR)
Time frame: approximately 24 months
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Pharmaceutical form:solution Route of administration: intravenous
Investigational Site Number 840007
Burbank, California, United States
Investigational Site Number 840001
New Haven, Connecticut, United States
Investigational Site Number 840202
Fort Meyers, Florida, United States
Investigational Site Number 840009
Atlanta, Georgia, United States
Investigational Site Number 840002
Boston, Massachusetts, United States
Investigational Site Number 056002
Haine-Saint-Paul, Belgium
Investigational Site Number 056005
Kortrijk, Belgium
Investigational Site Number 056001
Leuven, Belgium
Investigational Site Number 056003
Namur, Belgium
Investigational Site Number 203003
Nový Jičín, Czechia
...and 28 more locations