MOLTO
Research type
Research Study
Full title
Single arm feasibility of multi-maintenance olaparib after disease recurrence in participants with platinum sensitive BRCAm high grade serous ovarian cancer
IRAS ID
210678
Contact name
Gordon Jayson
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Eudract number
2015-003883-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 4 days
Research summary
Summary of Research
Single arm feasibility of multi-maintenance olaparib after disease recurrence in participants with platinum sensitive BRCAm high grade serous ovarian cancer.
PARP inhibitors, such as olaparib, significantly improve progression free survival (PFS) in participants with recurrent, platinum-sensitive high-grade serous/endometrioid ovarian cancer (HGS/EOC), who harbour a germline mutation in BRCA 1 or 2 genes. Despite some of the most impressive hazard ratios seen in ovarian oncology, such improvements in PFS have not translated into improved overall survival (OS) advantage potentially because maintenance poly ADP ribose polymerase inhibitors (PARPi) are only being administered during a single remission. In this study, we will test the feasibility of administering a second course of olaparib in participants who have recurrent platinum-sensitive HGS/EOC.Participants with HGS/EOC, whose disease has responded to platinum-based chemotherapy, will be treated with oral olaparib until progressive disease occurs. Following disease progression, they will then receive a further course of platinum-containing chemotherapy and providing their disease is stable or has responded a further course of olaparib will be prescribed in one of two settings.
1. For participants who have a platinum-free interval of less than 6 months (26 weeks) duration, the maintenance therapy will be olaparib with cediranib.
2. For participants who have a platinum-free interval of 6 months (26 weeks) or more duration, the maintenance therapy will be olaparib alone.The estimated duration of participation for a participant is 22.5 months and twenty evaluable participants will enter the trial.
Summary of Results
One course of olaparib is effective as a maintenance therapy in women diagnosed with relapsed ovarian cancer. The MOLTO trial assessed whether a second course of olaparib maintenance therapy could be given to women diagnosed with relapsed ovarian cancer that have an inherited BRCA1 or BRCA2 mutation. We found that a second course of olaparib could be feasibly administered to patients, was generally safe and tolerated, but, was only modestly effective.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0825
Date of REC Opinion
1 Feb 2017
REC opinion
Further Information Favourable Opinion