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Trial Title:
Itraconazole to Prevent Recurrent Barrett's Esophagus
NCT ID:
NCT05609253
Condition:
Barrett Oesophagitis With Dysplasia
Conditions: Official terms:
Barrett Esophagus
Esophagitis
Itraconazole
Hydroxyitraconazole
Conditions: Keywords:
Barrett's esophagus
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
The primary purpose is to determine the ideal formulation (capsule versus solution) of
itraconazole in this short-term pilot study.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Itraconazole in capsule form
Description:
Patients with high-risk BE will receive two weeks of itraconazole in the capsule form
(N=5).
Arm group label:
Itraconazole in capsule form
Intervention type:
Drug
Intervention name:
Itraconazole in solution form
Description:
Patients with high-risk BE will receive two weeks of itraconazole in the solution form
(N=5).
Arm group label:
Itraconazole in solution form
Summary:
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Start date:
September 14, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
University of Kansas Medical Center
Agency class:
Other
Collaborator:
Agency:
University of Texas, Southwestern Medical Center at Dallas
Agency class:
Other
Source:
University of Kansas Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609253
