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Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus

This study is currently recruiting participants.
Verified November 2012 by Columbia University
Sponsor:
Collaborator:
Trio Medicines Ltd.
Information provided by (Responsible Party):
Julian A Abrams, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01298999
First received: February 14, 2011
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Barrett's Esophagus
 Drug: YF476
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Placebo-Controlled Trial of YF476, a Gastrin Receptor Antagonist, in Barrett's Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cellular proliferation [ Time Frame: Up to 3 months from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in biomarker expression [ Time Frame: Up to 3 months from baseline ] [ Designated as safety issue: No ]
  • Number of participants with adverse events (any adverse events and/or severe adverse events) as a measure of safety and tolerability. [ Time Frame: Up to 4 weeks after completion of study drug ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YF476
YF476 (gastrin-receptor antagonist)
 Drug: YF476
Subjects will take YF476, 25 mg capsules, once daily, for three months.
Placebo Comparator: Placebo
Placebo pill (identical in appearance to YF476 pills)
 Drug: Placebo
Subjects will take placebo pill (identical in appearance to YF476 pills) once daily for 3 months.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298999

Contacts
Contact: Adriana Rodriguez 212-304-5606 ar2059@columbia.edu

Locations
United States, New York
New York Presbyterian Hospital - Columbia Recruiting
New York, New York, United States, 10032
Contact: Adriana Rodriguez     212-304-5606     ar2059@columbia.edu    
Sponsors and Collaborators
Julian A Abrams, MD
Trio Medicines Ltd.
Investigators
Principal Investigator: Julian A Abrams, MD, MS Columbia University
  More Information

No publications provided

Responsible Party: Julian A Abrams, MD, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01298999     History of Changes
Other Study ID Numbers: AAAE9648, YFBE-001
Study First Received: February 14, 2011
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Barrett's esophagus
Esophageal adenocarcinoma
GERD
Acid Reflux

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Gastrins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013