YF476 in Barrett's Esophagus

Inclusion Criteria

• Aged >18 years, with histologically confirmed diagnosis of Barrett's esophagus (BE) without dysplasia. A prior endoscopy with biopsies read as indefinite for dysplasia is permitted if biopsies from the most recent endoscopy prior to study entry demonstrated BE without dysplasia.
• Minimum of 1 cm circumferential Barrett's mucosa on endoscopy or at least 2 cm maximal contiguous extent of Barrett's mucosa, as measured from the top of the gastric folds to the squamocolumnar junction (Prague criteria C>1, any M or any C, M>2).
• Proton pump inhibitor use at least once daily, for at least 12 months prior to enrolment, and stable dose of PPI for the 3 months before enrolment. Any PPI, dose, and frequency allowable.
• ECOG performance status 60%
• Normal organ and marrow function, defined as white blood cells >3 x 10e9, absolute neutrophil count >1.5 x 10e9, platelets >100 x 10e9, creatinine 450 msec.
• History of allergic reactions attributed to compounds of similar chemical composition of YF476.
• History of baseline findings of:
• diabetes mellitus requiring insulin therapy
• pancreatitis (baseline amylase and/or lipase >2.0 x ULN)
• hepatitis B, hepatitis C or HIV
• malabsorption syndrome or inability to swallow or retain oral medicine
• major surgery 2
• another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in-situ
• also, any clinically significant and uncontrolled major morbidity including but not limited to: serious cardiac disease (unstable angina, s/p myocardial infarction 3 years from the time of enrolment, and the patient is not up to date with surveillance for that cancer (based on the American Cancer Society guidelines, Columbia University only), has evidence of cancer at the time of enrolment, or has surveillance tests planned within 21 weeks after enrolment.