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Randomized Placebo-Controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus

Phase 2
18 Years
90 Years
Open (Enrolling)
Barrett's Esophagus

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Trial Information

Randomized Placebo-Controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus

The association between gastro-esophageal reflux disease (GERD) and cancer of the esophagus
is well-established. Barrett's esophagus (BE) is a condition in which the lining of the part
of the esophagus changes to look like small intestine, and this change occurs in the setting
of GERD. Patients with BE are at increased risk for developing esophageal cancer. It is
recommended that all patients with BE take medicines called proton pump inhibitors (PPIs),
which greatly reduce the acid produced by the stomach, in the hopes of reducing the risk of
esophageal cancer. However, by reducing the acid level in the stomach, levels of a hormone
called gastrin are increased. There is laboratory data to suggest that gastrin may have
effects that actually promote the development of cancer, including esophageal cancer. The
investigators previously showed that BE patients with very high gastrin levels are more
likely to have either advanced precancerous changes (also called high grade dysplasia) or
cancer of the esophagus. As such, the obvious question is raised: does gastrin promote the
development of cancer in BE? YF476 is a new drug that blocks the effects of gastrin.
Trials in healthy subjects have demonstrated that the drug is safe and well-tolerated. The
investigators therefore propose to conduct a randomized placebo-controlled trial of YF476 in
patients with Barrett's esophagus. The primary hypothesis is that treatment with YF476 will
reduce the expression of tissue markers that are associated with an increased risk of
developing esophageal cancer.

Inclusion Criteria:

- Histologically confirmed diagnosis of Barrett's esophagus

- Ability to tolerate PPIs

- Age >18

Exclusion Criteria:

- History of histologically confirmed BE with LGD, HGD, or EAC

- History of endoscopic therapy for BE

- History of atrophic gastritis, pernicious anemia, or Zollinger-Ellison syndrome

- Any history of esophageal or gastric surgery

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Cellular proliferation

Outcome Time Frame:

Up to 3 months from baseline

Safety Issue:


Principal Investigator

Julian A Abrams, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

  • Barrett's Esophagus
  • Barrett's esophagus
  • Esophageal adenocarcinoma
  • GERD
  • Acid Reflux
  • Barrett Esophagus



New York Presbyterian Hospital - Columbia New York, New York  10032