Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Itraconazole drug and blood levels
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Itraconazole in solution form
Participants in this arm will receive the solution form of itraconazole
干预措施: Itraconazole in solution form (Drug)
Itraconazole in capsule form
Participants in this arm will receive the capsule form of itraconazole
干预措施: Itraconazole in capsule form (Drug)
结局指标
主要结局
Itraconazole drug and blood levels
时间窗: 8-12 months after study initiation
The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.
次要结局
- Effects of itraconazole on Gli1 expression(8-12 months after study initiation)
- Effects of itraconazole on angiogenesis(8-12 months after study initiation)
- Safety and tolerability of itraconazole(8-12 months after study initiation)
- Effects of itraconazole on (Patched) PTCH expression(8-12 months after study initiation)
- Effects of itraconazole on AKT pathway(8-12 months after study initiation)