Itraconazole to Prevent Recurrent Barrett's Esophagus

University of Kansas

Status and phase: Active, not recruiting; Phase 1

Conditions: Barrett Oesophagitis With Dysplasia

Treatments: Drug: Itraconazole in solution form; Drug: Itraconazole in capsule form

Study type: Interventional

Funder types: Other

Identifiers

NCT05609253

00148341

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Itraconazole in capsule form

Active Comparator group

Description:

Participants in this arm will receive the capsule form of itraconazole

Treatment:

Drug: Itraconazole in capsule form

Itraconazole in solution form

Active Comparator group

Description:

Participants in this arm will receive the solution form of itraconazole

Treatment:

Drug: Itraconazole in solution form