SOlar
Research type
Research Study
Full title
A translational phase II study of single agent Olaparib in the treatment of advanced oesophagogastric cancer
IRAS ID
234206
Contact name
Dr Naureen Starling
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2018-000454-22
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Gastric and oesophageal cancers are a significant health burden and are a leading cause of cancer related death. Despite improvements in survival over the last 4 decades overall the outcomes remain poor. In patients with advanced disease the outlook is particularly bleak with survival rates of less than one year with first line chemotherapy. New treatments are urgently needed to improve the poor survival rates in these cancers.
SOlar is a multi-centre phase II clinical trial of single agent olaparib in advanced oesophagogastric cancer. Olaparib is a PARP inhibitor which blocks poly(ADP-ribose) polymerase (PARP) 1, an enzyme which is involved in repair of damaged DNA. By inhibiting PARP1 olaparib prevents repair of damaged DNA. Cells with unrepaired DNA cannot survive and die.
This trial is designed to assess the efficacy and safety/tolerability of olaparib in patients with advanced oesophagogastric cancer. It will be conducted in two stages:
- The first stage will evaluate the efficacy of olaparib in 27 patients. If 5 or more patients have control of their disease at 8 weeks then the study will progress to stage 2.
- The second stage will evaluate disease control in a further 27 patients. If 12 or more patients have disease control out of 54 then it will be concluded that the treatment has shown anti-tumour activity of more than 30% and warrants further investigation. An investigation of potential biomarkers of response will be carried out to investigate whether response is higher in some subgroups.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/2142
Date of REC Opinion
4 Jan 2019
REC opinion
Favourable Opinion