DUETTE
Research type
Research Study
Full title
A Phase II Randomised, 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
IRAS ID
1003062
Contact name
Susana Banerjee
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-003791-39
Research summary
AstraZeneca is sponsoring a study which aims to investigate second maintenance treatment in participants with Platinum Sensitive Relapsed (PSR) epithelial ovarian cancer, who have previously received PARP inhibitor maintenance treatment.
Ovarian cancer remains one of the most difficult cancers to diagnose at an early curable stage; 75% of patients present with advanced disease (Stage III or IV). The majority of
patients die from their disease, with only 29% of patients with advanced cancer still alive after 5 years. Ovarian cancer is therefore an important public health issue.
Olaparib is a potent PARP (poly ADP ribose polymerase) inhibitor, which is an enzyme that helps repair DNA damage. Olaparib is being developed as an oral therapy, both as a
monotherapy i.e. olaparib alone (including maintenance) and for combination with chemotherapy and other anticancer agents. Ceralasertib is currently being developed in
various cancer types as a treatment on its own and in combination with other drugs including olaparib.
Pre-clinical data has shown promising results for a combination approach of olaparib+ceralasertib. Emerging clinical data is also supportive of this treatment combination.
Participants will be randomly assigned in a 1:1:1 ratio to the following 3 treatment
arms:
• Arm 1 – ceralasertib + olaparib
• Arm 2 – olaparib monotherapy
• Arm 3 – placebo
Arm 1 will be open-label (i.e. both participants and study doctor know which treatment
participants are receiving). Arms 2 and 3 will be double-blinded (i.e. participants and
study doctors do not know the treatment the participant is receiving).
Participants will be recruited from approximately 120 study sites in the United States of America, Canada, the Middle East, and Europe. Overall, the study will last for approximately four years, however the duration of a participant’s time in the trial will be approximately two years.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0110
Date of REC Opinion
4 Sep 2020
REC opinion
Further Information Favourable Opinion