Netazepide (YF476) in patients with Barrett's oesophagus; version 1
Research type
Research Study
Full title
Randomized, placebo-controlled trial of YF476, a gastrin receptor antagonist, in Barrett’s esophagus (10-505; T-016)
IRAS ID
159034
Contact name
Rebecca Fitzgerald
Contact email
Sponsor organisation
Hammersmith Medicines Research
Eudract number
2014-002418-22
Clinicaltrials.gov Identifier
Research summary
YF476 (the study medicine) is an experimental treatment for Barrett's oesophagus (BO). The oesophagus is the pipe that carries food from the mouth to the stomach. In BO the tissue lining of the oesophagus is abnormal. BO can develop in some people who have heartburn, acid in the oesophagus (acid reflux disease), or inflammation of the oesophagus (oesophagitis). Patients with BO have a higher risk of developing cancer of the oesophagus. Currently, there is no effective way to prevent this type of cancer in people at increased risk.
BO patients are treated with medicines, called proton pump inhibitors (PPIs), that suppress the production of stomach acid. In this study, BO patients will take YF476 (or placebo) in combination with a PPI for 12 weeks. We hope that the combination of YF476 and a PPI will be a more effective treatment for BO and reduce the risk of BO patients developing cancer of the oesophagus.
We aim to find out the effects of YF476 on the levels of substances (biomarkers) linked to cell growth, cancer of the oesophagus, and the way the body handles and responds to YF476. To do that, we will take tissue samples (biopsies) of different parts of the oesophagus and blood samples, before and after treatment.
22 BO patients will take part in the study. They’ll make up to 5 outpatient visits and take up to 18 weeks to finish the study.
A pharmaceutical company, Trio Medicines Ltd, is providing the study medicine.
The study will take place at 1 centre in the UK (National Institute for Health Research Clinical Investigation Ward (NIHR CIW) in Cambridge) and 1 centre in the US (Columbia University Medical Center in New York).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1305
Date of REC Opinion
7 Nov 2014
REC opinion
Further Information Favourable Opinion