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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
No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
Secondary study objectives
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 F: Uprifosbuvir 300 mg (Tablet)
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Groups C & D: Uprifosbuvir 400 mg (Capsule)
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Group A: Placebo (Cohort 6a)
Group B: Uprifosbuvir 25 mg (Cohort 2b)
Groups C & D: Uprifosbuvir 250 mg (Capsule)
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~830

Find a Location

Who is running the clinical trial?

Dallas VA Medical CenterLead Sponsor
34 Previous Clinical Trials
4,818 Total Patients Enrolled
David Wang, MD, PhDPrincipal InvestigatorNorth Texas Veterans Healthcare System
1 Previous Clinical Trials
78 Total Patients Enrolled
~2 spots leftby Nov 2025
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