Spots Global Cancer Trial Database for Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
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Trial Identification
Brief Title: Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel
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
Study ID: NCT01332656
Conditions
Study Description
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
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Novy Jicin, , Czech Republic
Investigational Site Number 203002, Olomouc, , Czech Republic
Investigational Site Number 203001, Praha 2, , Czech Republic
Investigational Site Number 203004, Zlin, , Czech Republic
Investigational Site Number 250006, Bordeaux, , France
Investigational Site Number 250004, Caen Cedex 05, , France
Investigational Site Number 250001, Lyon, , France
Investigational Site Number 250002, Paris Cedex 4, , France
Investigational Site Number 250003, Villejuif, , France
Investigational Site Number 276001, München, , Germany
Investigational Site Number 380004, Genova, , Italy
Investigational Site Number 380003, Milano, , Italy
Investigational Site Number 380001, Roma, , Italy
Investigational Site Number 616002, Krakow, , Poland
Investigational Site Number 616004, Poznan, , Poland
Investigational Site Number 616003, Rybnik, , Poland
Investigational Site Number 616005, Warszawa, , Poland
Investigational Site Number 616001, Warszawa, , Poland
Investigational Site Number 643002, Moscow, , Russian Federation
Investigational Site Number 643003, Moscow, , Russian Federation
Investigational Site Number 643001, Moscow, , Russian Federation
Investigational Site Number 643004, Saint-Petersburg, , Russian Federation
Investigational Site Number 724002, Barcelona, , Spain
Investigational Site Number 724003, Madrid, , Spain
Investigational Site Number 724001, Madrid, , Spain
Investigational Site Number 804003, Dnipropetrovsk, , Ukraine
Investigational Site Number 804005, Donetsk, , Ukraine
Investigational Site Number 804004, Kharkov, , Ukraine
Investigational Site Number 804002, Lviv, , Ukraine
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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