University of Kansas Medical Center is starting a new clinical trial of 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
The clinical trial started on September 14, 2022 and will continue throughout December 2023.
Itraconazole drug and blood levels will be primary outcome measure. The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.
Participants must have 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. Besides, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Excluded from participation are any patients who are unable to provide informed consent, those with: 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.
The contacts and locations are the University of Kansas Medical Center, Kansas City, Kansas, United States. For more details: https://ichgcp.net/clinical-trials-registry/NCT05609253.