Itraconazole for Barrett's Esophagus

Overseen By Jill Torneden

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Kansas Medical Center

Must not be taking: CYP3A4 drugs

Disqualifiers: CHF, Liver dysfunction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 months

10 Participants Needed

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it excludes people with critical drug interactions with medications metabolized by cytochrome P450 (CYP)3A4. It's best to discuss your current medications with the trial team.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive itraconazole in either solution or capsule form to prevent recurrent Barrett's esophagus

8-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of itraconazole effects on angiogenesis and molecular pathways

4 weeks

Treatment Details

Interventions

• Itraconazole

Trial Overview 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.

Participant Groups

Group I: Itraconazole in solution form Active Control 1 Intervention

Participants in this arm will receive the solution form of itraconazole

Group II: Itraconazole in capsule form Active Control 1 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:

• Fungal infections
• Histoplasmosis
• Aspergillosis
• Blastomycosis

Approved in European Union as Sporanox for:

• Fungal infections
• Histoplasmosis
• Aspergillosis
• Blastomycosis

Approved in Canada as Sporanox for:

• Fungal infections
• Histoplasmosis
• Aspergillosis
• Blastomycosis

Approved in Japan as Sporanox for:

• Fungal infections
• Histoplasmosis
• Aspergillosis
• Blastomycosis

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials

18

Recruited

21,200+