NCT02749513

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

3.7 years

First QC Date

April 14, 2016

Last Update Submit

November 2, 2021

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Inhibition of Hedgehog pathway signaling as measured by real-time PCR.

    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.

    2-3 weeks

Secondary Outcomes (1)

  • Inhibition of VEGFR2 pathway signaling as measured by Western blot

    2-3 weeks

Study Arms (1)

Itraconazole

EXPERIMENTAL

Itraconazole 300 mg po bid for 14-17 days

Drug: Itraconazole

Interventions

ItraconazoleDRUG
Itraconazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (3)

  • Kim DJ, Kim J, Spaunhurst K, Montoya J, Khodosh R, Chandra K, Fu T, Gilliam A, Molgo M, Beachy PA, Tang JY. Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):745-51. doi: 10.1200/JCO.2013.49.9525. Epub 2014 Feb 3.

    PMID: 24493717RESULT

  • Antonarakis ES, Heath EI, Smith DC, Rathkopf D, Blackford AL, Danila DC, King S, Frost A, Ajiboye AS, Zhao M, Mendonca J, Kachhap SK, Rudek MA, Carducci MA. Repurposing itraconazole as a treatment for advanced prostate cancer: a noncomparative randomized phase II trial in men with metastatic castration-resistant prostate cancer. Oncologist. 2013;18(2):163-73. doi: 10.1634/theoncologist.2012-314. Epub 2013 Jan 22.

    PMID: 23340005RESULT

  • Zhang W, Bhagwath AS, Ramzan Z, Williams TA, Subramaniyan I, Edpuganti V, Kallem RR, Dunbar KB, Ding P, Gong K, Geurkink SA, Beg MS, Kim J, Zhang Q, Habib AA, Choi SH, Lapsiwala R, Bhagwath G, Dowell JE, Melton SD, Jie C, Putnam WC, Pham TH, Wang DH. Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer By Suppressing the HER2/AKT Signaling Pathway. Mol Cancer Ther. 2021 Oct;20(10):1904-1915. doi: 10.1158/1535-7163.MCT-20-0638. Epub 2021 Aug 10.

    PMID: 34376577DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • David Wang, MD, PhD

    North Texas Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Hematology-Oncology

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 25, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2019

Study Completion

October 1, 2022

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations

US(1)