NCT02749513Unknown早期 1 期
Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
研究概览
简要总结
The purpose of this study is to demonstrate that orally administered itraconazole, a commonly used antifungal medication, can inhibit Hedgehog pathway signaling in patients with esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer
排除标准
- •Patients unwilling or unable to provide informed consent
- •Coagulopathy that precludes safe endoscopic/surgical procedure (platelet count <100,000/mm3, INR>1.5)
- •Esophageal varices
- •Comorbidity (e.g. pulmonary, cardiac, renal, or liver disease) that precludes safe participation in the study
- •QTc>450 ms
- •LFT's>3xULN
- •Pregnancy
- •Allergy to itraconazole
- •History of symptomatic congestive heart failure
研究组 & 干预措施
Itraconazole
Experimental
Itraconazole 300 mg po bid for 14-17 days
干预措施: Itraconazole (Drug)
结局指标
主要结局
Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
时间窗: 2-3 weeks
mRNA expression levels as measured by real-time PCR of Hedgehog pathway ligands and target genes will be compared between baseline and post-itraconazole treatment.
次要结局
- Inhibition of VEGFR2 pathway signaling as measured by Western blot(2-3 weeks)
研究者
David Wang
Staff Physician, Hematology-Oncology
Dallas VA Medical Center
研究点 (1)
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