Monitor

Status: Open

Specialty: Gynae

Date Opened: 06/03/2020

Planned Close Date: 03/05/2024 

Sponsor: The Royal Marsden NHS Foundation Trust 

Principal Investigator: Dr Sarah Moon

Study Title: Multi-centre Observational study of maintenance Niraparib in Treatment of Ovarian CanceR: UK routine clinical practice experience 

Ovarian cancer is diagnosed in over 7000 women per year and is the cause of over 4000 deaths per year in the UK. Around 70% of patients experience disease recurrence within the first 3 years of diagnosis. Maintenance treatment strategies have been developed to improve patient outcomes. Maintenance treatment with Niraparib slows cancer growth by blocking a group of enzymes called poly [ADP-ribose] polymerase (PARP) that are implicated in DNA repair.

The purpose of this study is to improve the knowledge and understanding of the tolerability and incidence and management of treatment emergent adverse events (TEAEs) during Niraparib treatment in patients with advanced ovarian fallopian tube and primary peritoneal cancer. All patients who have already commenced treatment and those who are due to commence Niraparib will be eligible to take part.

This is a multicentre observational study which will aim to collect and analyse the records of 200 patients in the UK who have been prescribed Niraparib as maintenance therapy for their cancer in order to determine how best the drug can be used within the British healthcare system. Data will be collected retrospectively for patients who have previously received Niraparib. Information on patients’ Quality of Life will be collected for all patients who have not received Niraparib when they enrol on the trial. They will be asked to complete several questionnaires at regular time points throughout the study.

The study will last for 2.5 years and will be funded by TESARO UK.