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

Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02749513

Enrollment

Registered

2016-04-25

Start date

2016-01-31

Completion date

2022-10-31

Last updated

2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Brief summary

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).

Interventions

DRUGItraconazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Inhibition of Hedgehog pathway signaling as measured by real-time PCR.	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.

Secondary

Measure	Time frame	Description
Inhibition of VEGFR2 pathway signaling as measured by Western blot	2-3 weeks	Protein expression levels of phosphorylated VEGFR2 will be compared between baseline and post-itraconazole treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026