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Antifungal Agent

Itraconazole for Esophageal Cancer

Phase < 1
Waitlist Available
Led By David Wang, MD, PhD
Research Sponsored by Dallas VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 weeks
Awards & highlights

Study Summary

This trial will test if itraconazole can help treat esophageal cancer by inhibiting the Hedgehog pathway.

Eligible Conditions
  • Esophageal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
Secondary outcome measures
Inhibition of VEGFR2 pathway signaling as measured by Western blot

Side effects data

From 2015 Phase 1 & 2 trial • 178 Patients • NCT01974687
33%
Pruritus generalised
33%
Dry skin
33%
Fatigue
33%
Pruritus
33%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Group A: Placebo (Cohort 6a)
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Groups C & D: Uprifosbuvir 250 mg (Capsule)
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Group F: Uprifosbuvir 300 mg (Tablet)
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Group A: Placebo (Cohort 1a - Cohort 5a - Pooled)
Group A: Uprifosbuvir 10 mg (Cohort 1a)
Group A: Uprifosbuvir 25 mg (Cohort 2a)
Group A: Uprifosbuvir 50 mg (Cohort 3a)
Group A: Uprifosbuvir 300 mg (Cohort 5a)
Groups C & D: Uprifosbuvir 450 mg (Tablet)
Groups C & D: Placebo (Pooled)
Group E: Uprifosbuvir 150 mg (Cohort 1e)
Group E: Uprifosbuvir 300 mg (Cohort 2e)
Group E: Uprifosbuvir 450 mg (Cohort 3e)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ItraconazoleExperimental Treatment1 Intervention
Itraconazole 300 mg po bid for 14-17 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,817 Total Patients Enrolled
David Wang, MD, PhDPrincipal InvestigatorNorth Texas Veterans Healthcare System
1 Previous Clinical Trials
78 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The OncologistJournal
Repurposing Itraconazole as a Treatment for Advanced Prostate Cancer: A Noncomparative Randomized Phase II Trial in Men with Metastatic Castration-resistant Prostate Cancer
Antonarakis, Emmanuel S., Elisabeth I. Heath, David C. Smith, Dana Rathkopf, Amanda L. Blackford, Daniel C. Danila, Serina King, et al.. 2013. “Repurposing Itraconazole as a Treatment for Advanced Prostate Cancer: A Noncomparative Randomized Phase II Trial in Men with Metastatic Castration-resistant Prostate Cancer”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.2012-314.
Journal of Clinical OncologyJournal
Open-label, Exploratory Phase II Trial of Oral Itraconazole for the Treatment of Basal Cell Carcinoma
Kim, Daniel J., James Kim, Katrina Spaunhurst, Javier Montoya, Rita Khodosh, Kalyani Chandra, Teresa Fu, et al.. 2014. “Open-label, Exploratory Phase II Trial of Oral Itraconazole for the Treatment of Basal Cell Carcinoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2013.49.9525.
The OncologistJournal
Repurposing Itraconazole as a Treatment for Advanced Prostate Cancer: A Noncomparative Randomized Phase II Trial in Men with Metastatic Castration-resistant Prostate Cancer
Antonarakis, Emmanuel S., Elisabeth I. Heath, David C. Smith, Dana Rathkopf, Amanda L. Blackford, Daniel C. Danila, Serina King, et al.. 2013. “Repurposing Itraconazole as a Treatment for Advanced Prostate Cancer: A Noncomparative Randomized Phase II Trial in Men with Metastatic Castration-resistant Prostate Cancer”. The Oncologist. Oxford University Press (OUP). doi:10.1634/theoncologist.2012-314.
Molecular Cancer TherapeuticsJournal
Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer by Suppressing the HER2/AKT Signaling Pathway
Zhang, Wei, Ankur S. Bhagwath, Zeeshan Ramzan, Taylor A. Williams, Indhumathy Subramaniyan, Vindhya Edpuganti, Raja Reddy Kallem, et al.. 2021. “Itraconazole Exerts Its Antitumor Effect in Esophageal Cancer by Suppressing the HER2/AKT Signaling Pathway”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-20-0638.
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