Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Texas, Southwestern Medical Center at Dallas | OTHER |
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole in capsule form | Active Comparator | Participants in this arm will receive the capsule form of itraconazole |
|
| Itraconazole in solution form | Active Comparator | Participants in this arm will receive the solution form of itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole in capsule form | Drug | Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Itraconazole drug and blood levels | The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole. | 8-12 months after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of itraconazole | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 8-12 months after study initiation |
| Effects of itraconazole on Gli1 expression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
The primary purpose is to determine the ideal formulation (capsule versus solution) of itraconazole in this short-term pilot study.
Not provided
Not provided
Not provided
Not provided
| Itraconazole in solution form | Drug | Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5). |
|
Reduction in Gli1 expression
| 8-12 months after study initiation |
| Effects of itraconazole on (Patched) PTCH expression | Reduction in PTCH expression by IHC | 8-12 months after study initiation |
| Effects of itraconazole on AKT pathway | Reduction in Phospho S6 by IHC | 8-12 months after study initiation |
| Effects of itraconazole on angiogenesis | Reduction in Vascular endothelial growth factor (VEGF)/ Vascular endothelial growth factor receptor type 2 (VEGFR2) by IHC | 8-12 months after study initiation |
| D004066 |
| Digestive System Diseases |
| D010879 |
| Piperazines |