Clinical Trials /

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

NCT02749513

Description:

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).

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients
  • Official Title: Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer

Clinical Trial IDs

  • ORG STUDY ID: 15-084
  • NCT ID: NCT02749513

Conditions

  • Esophageal Cancer

Interventions

DrugSynonymsArms
ItraconazoleItraconazole

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
ItraconazoleExperimentalItraconazole 300 mg po bid for 14-17 days
  • Itraconazole

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
Time Frame:2-3 weeks
Safety Issue:
Description: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 Outcome Measures

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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dallas VA Medical Center

Last Updated