Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Intervention: YF476; Placebo
Intervention description: 25 mg: one capsule to be taken by mouth once daily for 12 weeks.; Matching placebo: one capsule to be taken by mouth once daily for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Barrett's Esophagus; Esophageal Adenocarcinoma; GERD; Acid Reflux

Summary:

      The purpose of this study is to determine whether treatment with an experimental drug called
      YF476 in patients with Barrett's esophagus reduces the expression of tissue markers that are
      associated with an increased risk of developing esophageal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years, with histologically confirmed diagnosis of Barrett's Esophagus
             without dysplasia

          -  Minimum of 1 cm circumferential Barrett's mucosa on endoscopy or at least 2 cm maximal
             contiguous extent of Barrett's mucosa

          -  Proton pump inhibitor use at least once daily for at least twelve months prior to
             enrolment, and stable dose of PPI for the three months before enrolment

          -  ECOG performance status ≤ 2 and Karnofsky ≥ 60%

          -  Normal organ and marrow function

          -  Use of adequate contraception during the study

          -  Willingness to comply with all treatment and follow up procedures

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Up to date with all age appropriate cancer screening tests, as per American Cancer
             Society guidelines

        Exclusion Criteria:

          -  Histologically confirmed BE with high grade dysplasia, invasive carcinoma of the
             esophagus, low grade dysplasia

          -  Prior endoscopic therapy for BE

          -  History of esophageal or gastric surgery

          -  History of atrophic gastritis, pernicious anemia, or Zollinger-Ellison syndrome

          -  Participation in a trial of an investigational medicinal product within the previous
             28 days

          -  Prolonged QTc interval >450 msec

          -  History of allergic reactions attributed to compounds of similar chemical composition
             to YF476

          -  History of baseline findings of: diabetes mellitus requiring insulin therapy;
             pancreatitis; hepatitis B, hepatitis C or HIV; malabsorption syndrome or inability to
             swallow or retain oral medicine; major surgery ≤ 28 days prior to enrollment; ECOG
             performance status ≥ 2; or another cancer within 3 years except for basal carcinoma of
             the skin or cervical carcinoma in situ; any clinically significant and uncontrolled
             major morbidity

          -  Certain medicines and herbal remedies taken during the 7 days before the start of
             study drug

          -  Has evidence of cancer at the time of enrolment, or has surveillance tests planned
             within 21 weeks after enrollment