A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. — DUETTE

Ovarian Cancer Clinical Trial

Official title:
A Phase 2 Randomized, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients With Platinum Sensitive Relapsed Epithelial Ovarian Cancer, Who Have Previously Received PARP Inhibitor Maintenance Treatment

Status Withdrawn

Clinical Trial Summary

To investigate the effectiveness and tolerability of a second maintenance treatment in participants with platinum-sensitivity relapsed (PSR) epithelial ovarian cancer, who have previously received PARPi maintenance treatment and who have benefit (complete response [CR] or partial response [PR]) or stable disease (SD) from further platinum based chemotherapy.

Clinical Trial Description

This is a Phase II, randomised, multicentre study to investigate the efficacy and tolerability of a second maintenance treatment in participants with PSR epithelial ovarian cancer, who have previously received PARPi maintenance treatment and who have benefit (CR or PR) or SD from further platinum based chemotherapy. Participants will be recruited globally from approximately 120 study sites in the USA, Canada, Middle East and Europe. Approximately 192 participants fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1 ratio to the following 3 treatment arms (64 participants per arm): - Arm 1 (ceralasertib+olaparib): Ceralasertib 160 mg once daily (QD) orally or per os (PO) on Days 1 to 7 plus olaparib 300 mg twice daily (BD) PO continuous (28 day cycle) - Arm 2 (olaparib monotherapy): Olaparib 300 mg BD PO daily continuous - Arm 3 (placebo): Placebo to match olaparib BD PO daily continuous The olaparib and placebo arms will be double blinded, whereas the ceralasertib+olaparib arm will be open label. It is expected that approximately 320 participants will be screened. The study achieved First Subject In date, but enrollment equals 0 as 7 participants have signed the Informed Consent Form (ICF) and were later screen failed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04239014
Study type	Interventional
Source	AstraZeneca
Contact
Status	Withdrawn
Phase	Phase 2
Start date	August 7, 2020
Completion date	January 25, 2021

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