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

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ClinicalTrials.gov Identifier: NCT02749513
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
David Wang, Dallas VA Medical Center

Tracking Information
First Submitted Date  ICMJE April 14, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02749513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients
Official Title  ICMJE Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE Drug: Itraconazole
Study Arms  ICMJE Experimental: Itraconazole
Itraconazole 300 mg po bid for 14-17 days
Intervention: Drug: Itraconazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Wang, MD, PhD 214-857-0737 davidh.wang@va.gov
Contact: Thai Pham, MD 214-857-1800 thai.pham2@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02749513
Other Study ID Numbers  ICMJE 15-084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party David Wang, Dallas VA Medical Center
Study Sponsor  ICMJE Dallas VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Wang, MD, PhD North Texas Veterans Healthcare System
PRS Account Dallas VA Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP