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NCT Number: NCT05609253

Itraconazole to Prevent Recurrent Barrett's Esophagus

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Barrett Oesophagitis With Dysplasia Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itraconazole in capsule form

Drug

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

Itraconazole in solution form

Drug

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

Primary outcomes

  1. Itraconazole drug and blood levels

    Time frame: 8-12 months after study initiation

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

Secondary outcomes

  1. Safety and tolerability of itraconazole

    Time frame: 8-12 months after study initiation

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Effects of itraconazole on Gli1 expression

    Time frame: 8-12 months after study initiation

    Reduction in Gli1 expression

  3. Effects of itraconazole on (Patched) PTCH expression

    Time frame: 8-12 months after study initiation

    Reduction in PTCH expression by IHC

  4. Effects of itraconazole on AKT pathway

    Time frame: 8-12 months after study initiation

    Reduction in Phospho S6 by IHC

  5. Effects of itraconazole on angiogenesis

    Time frame: 8-12 months after study initiation

    Reduction in Vascular endothelial growth factor (VEGF)/ Vascular endothelial growth factor receptor type 2 (VEGFR2) by IHC

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

Registry information

Official study title

Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 8, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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