Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julian A Abrams, MD
• Collaborators: National Institute for Health Research, United Kingdom; Trio Medicines Ltd.
• Treatments: Gastrins

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