Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients

Dallas VA Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Esophageal Cancer

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02749513

15-084

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Itraconazole

Experimental group

Description:

Itraconazole 300 mg po bid for 14-17 days

Treatment:

Drug: Itraconazole