Gastric Cancer Clinical Trial
Official title:
A Translational Phase II Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer
SOlar is a multi-centre phase II clinical trial of single agent olaparib in advanced oesophagogastric cancer.
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.
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