Itraconazole to Prevent Recurrent Barrett's Esophagus

NCT05609253 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 00148341
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Barrett Oesophagitis With Dysplasia

Keywords

Barrett's esophagus

Outcome Measures

Primary Outcomes (1)

• Itraconazole drug and blood levels

  The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.

  8-12 months after study initiation

Secondary Outcomes (5)

• Safety and tolerability of itraconazole

  8-12 months after study initiation

• Effects of itraconazole on Gli1 expression

  8-12 months after study initiation

• Effects of itraconazole on (Patched) PTCH expression

  8-12 months after study initiation

• Effects of itraconazole on AKT pathway

  8-12 months after study initiation

• Effects of itraconazole on angiogenesis

  8-12 months after study initiation

Study Arms (2)

Itraconazole in capsule form

ACTIVE COMPARATOR

Participants in this arm will receive the capsule form of itraconazole

Drug: Itraconazole in capsule form

Itraconazole in solution form

ACTIVE COMPARATOR

Participants in this arm will receive the solution form of itraconazole

Drug: Itraconazole in solution form

Interventions

Itraconazole in capsule form DRUG

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

Itraconazole in capsule form

Itraconazole in solution form DRUG

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

Itraconazole in solution form

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: November 8, 2022
• Study Start: September 14, 2022
• Primary Completion: February 23, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)