This site is intended for healthcare professionals
A close up image of a microscope
  • Home
  • /
  • Clinical trials
  • /
  • Ovarian Cancer
  • /
  • A Study to Evaluate the Effectiveness and Tolerabi...
Clinical trial

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)

Read time: 1 mins
Last updated:27th Jan 2021
Status: Recruiting
Identifier: NCT04239014
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)


Brief 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.

Detailed 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The olaparib and placebo arms will be double blinded, whereas the ceralasertib+olaparib arm will be open label.
Primary Purpose: Treatment
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
Actual Study Start Date: August 7, 2020
Estimated Primary Completion Date: December 16, 2022
Estimated Study Completion Date: February 20, 2023

Arm:
- Experimental: Arm 1 (ceralasertib+olaparib)
- Experimental: Arm 2 (olaparib monotherapy)
- Experimental: Arm 3 (placebo)

Category Value
Study type(s) Interventional
Expected enrolment 192
Actual Study start date 07 August 2020
Estimated Study Completion Date 20 February 2023

View full details