Itraconazole to Prevent Recurrent Barrett's Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2026-06-30

Brief Summary

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Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure

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Detailed Description

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Conditions

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Barrett Oesophagitis With Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The primary purpose is to determine the ideal formulation (capsule versus solution) of itraconazole in this short-term pilot study.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Itraconazole in capsule form

Participants in this arm will receive the capsule form of itraconazole

Group Type ACTIVE_COMPARATOR

Itraconazole in capsule form

Intervention Type DRUG

Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5).

Itraconazole in solution form

Participants in this arm will receive the solution form of itraconazole

Group Type ACTIVE_COMPARATOR

Itraconazole in solution form

Intervention Type DRUG

Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5).

Interventions

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Itraconazole in capsule form

Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5).

Intervention Type DRUG

Itraconazole in solution form

Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria

* Inability to provide informed consent, New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)\>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (\>450 ms for men and QTc\>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No