Itraconazole for Barrett's Esophagus

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for patients with Barrett's esophagus who may have low to high-grade dysplasia or early-stage cancer and are set for endoscopic treatment. They should be relatively active (ECOG 0-2). It's not for those unable to consent, with severe heart failure, liver issues, allergy to itraconazole, pregnant women, or those on certain other drugs.

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

Rewritten Criteria: - You cannot understand and agree to participate in the study. - You have severe heart failure. - Your liver function tests are three times higher than normal. - You are allergic to itraconazole. - You are pregnant. - Your heart's electrical system has a prolonged QTc, which can be dangerous. - The medication you are taking interacts badly with the study drug.

Participant Groups

The study tests Itraconazole in capsule and solution forms as a preventive treatment against the recurrence of Barrett's Esophagus after initial successful therapy. The goal is to improve long-term outcomes by preventing relapse which could lead to cancer.

2Treatment groups

Active Control

Group I: Itraconazole in solution formActive Control1 Intervention

Participants in this arm will receive the solution form of itraconazole

Group II: Itraconazole in capsule formActive Control1 Intervention

Participants in this arm will receive the capsule form of itraconazole

Itraconazole is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Sporanox for: