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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02749513
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
David Wang, Dallas VA Medical Center

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).

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Itraconazole Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Itraconazole
Itraconazole 300 mg po bid for 14-17 days
Drug: Itraconazole

Primary Outcome Measures :
  1. Inhibition of Hedgehog pathway signaling as measured by real-time PCR. [ Time Frame: 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 Outcome Measures :
  1. Inhibition of VEGFR2 pathway signaling as measured by Western blot [ Time Frame: 2-3 weeks ]
    Protein expression levels of phosphorylated VEGFR2 will be compared between baseline and post-itraconazole treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02749513

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United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
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Principal Investigator: David Wang, MD, PhD North Texas Veterans Healthcare System
Publications of Results:
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Responsible Party: David Wang, Staff Physician, Hematology-Oncology, Dallas VA Medical Center Identifier: NCT02749513    
Other Study ID Numbers: 15-084
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors