Last updated on June 2019

A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.


Brief description of study

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).

Detailed Study Description

The OReO study will investigate the efficacy and safety of Olaparib maintenance re-treatment in patients with relapsed non-mucinous EOC, who have had disease progression following maintenance therapy with a Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation inhibitor (PARPi) and a complete or partial radiological response to subsequent treatment with platinum-based chemotherapy or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125. Patients will be enrolled on the basis of their breast cancer susceptibility gene (BRCA1, BRCA2) status into one of two cohorts (BRCA1/2 [+ve] and BRCA1/2 [-ve]). The BRCA1/2 (+ve) and BRCA1/2 (-ve) cohorts will be randomised separately. Within each cohort, patients will be randomised by prospective allocation in a 2:1 ratio (Olaparib: matching placebo).

Clinical Study Identifier: NCT03106987

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Brussels, Belgium
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London, ON Canada
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Montreal, QC Canada
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Aalborg, Denmark
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København Ø, Denmark
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Odense C, Denmark
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Besançon, France
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Bordeaux Cedex, France
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Caen Cedex 05, France
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Clermont Ferrand cedex 01, France
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Lille Cedex, France
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Marseille, France
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Montpellier, France
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Paris Cedex 20, France
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Paris Cedex 5, France
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Pierre Benite, France
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Plerin SUR MER, France
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Saint Herblain, France
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Saint-cloud, France
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Toulouse Cedex 09, France
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Vandoeuvre-Les-Nancy, France
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Villejuif, France
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Dresden, Germany
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Frankfurt, Germany
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Greifswald, Germany
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Lübeck, Germany
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Mannheim, Germany
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München, Germany
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Regensburg, Germany
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Rostock, Germany
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Stuttgart, Germany
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Wiesbaden, Germany
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Jerusalem, Israel
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Kfar Saba, Israel
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petach Tikva, Israel
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Ramat Gan, Israel
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Tel-Aviv, Israel
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Reggio Emilia, Italy
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Grzepnica, Poland
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København Ø, Denmark
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Besançon, France
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Lübeck, Germany
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München, Germany
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København Ø, Denmark
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Besançon, France
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Lübeck, Germany
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München, Germany
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København Ø, Denmark
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Besançon, France
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Lübeck, Germany
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München, Germany
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Plerin Sur Mer, France
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Recruitment Status: Open


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