NCT03829345

A Translational Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer

A Translational Phase II Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SOlar is a multi-centre phase II clinical trial of single agent olaparib in advanced oesophagogastric cancer.

Detailed description

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. 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 4 or fewer patients have control of their disease at 8 weeks then the trial for the olaparib arm will stop and no further patients will be recruited to the study. If 5-13 patients have control of their disease at 8 weeks then the study will progress to stage 2. If 14 or more patients have disease control at 8 weeks then a larger study may be opened in an unselected population. * The second stage will evaluate disease control in a further 27 patients. This is to allow identification of potential biomarkers of response.

Conditions

• Oesophageal Cancer
• Gastro-Oesophageal Junction Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Patients will be administered olaparib orally twice daily (BD) at 300mg continuously for each 28 day cycle.

Timeline

• Start date: 2019-07-02
• Primary completion: 2021-02-14
• Completion: 2022-02-14
• First posted: 2019-02-04
• Last updated: 2019-07-08

Locations

2 sites across 1 country: United Kingdom