Clinical trial · Interventional
Itraconazole to Prevent Recurrent Barrett's Esophagus
Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Oesophagitis With Dysplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itraconazole in capsule form | Drug | — | UNRESOLVED |
| Itraconazole in solution form | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Itraconazole in capsule form
- description
- Participants in this arm will receive the capsule form of itraconazole
- interventionNames
- Drug: Itraconazole in capsule form
- type
- ACTIVE_COMPARATOR
- label
- Itraconazole in solution form
- description
- Participants in this arm will receive the solution form of itraconazole
- interventionNames
- Drug: Itraconazole in solution form
Primary outcomes (1)
- measure
- Itraconazole drug and blood levels
- timeFrame
- 8-12 months after study initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available