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Itraconazole for Esophageal Cancer

Phase 2
Recruiting
Led By David H Wang, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the effect of itraconazole, a widely used anti-fungal medication, as a neoadjuvant therapy added to standard of care chemoradiation and surgery in the treatment of esophageal cancer.

Who is the study for?
This trial is for individuals who can consent and have been diagnosed with resectable esophageal or gastroesophageal junction cancer, planning to undergo chemoradiation and surgery. They should be relatively active (WHO/ECOG status 0-2) and have good kidney and liver function.
What is being tested?
The trial tests Itraconazole as an add-on to standard care in treating locoregional esophageal cancers. It's a phase II study, meaning it focuses on the drug's effectiveness when combined with chemotherapy, radiation therapy, and surgery.
What are the potential side effects?
Itraconazole may cause liver issues, heart problems like congestive heart failure (especially if there's a history), allergic reactions in those sensitive to it, potential pregnancy risks, and could lengthen QTc interval which affects heart rhythm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 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
Itraconazole
Secondary study objectives
Interventional procedure
Correlation of peripheral blood and esophageal tissue levels of itraconazole and hydroxyitraconazole with pathologic response
Determine the utility of ctDNA and exosome characterization as a prognostic marker
+1 more

Side effects data

From 2015 Phase 1 & 2 trial • 178 Patients • NCT01974687
30%
Diarrhoea
20%
Back pain
10%
Neutropenia
10%
Vessel puncture site haematoma
10%
Oropharyngeal pain
10%
Skin odour abnormal
10%
Visual acuity reduced
10%
Constipation
10%
Tremor
10%
Dermatosis
10%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Groups C & D: Uprifosbuvir 150 mg (Capsule)
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Group B: Uprifosbuvir 150 mg (Cohort 4b)
Group A: Uprifosbuvir 300 mg (Cohort 6a)
Group B: Uprifosbuvir 10 mg (Cohort 1b)
Group B: Uprifosbuvir 300 mg (Cohort 5b)
Group B: Uprifosbuvir 50 mg (Cohort 3b)
Groups C & D: Uprifosbuvir 50 mg (Capsule)
Group F: Uprifosbuvir 300 mg (Tablet)
Groups C & D: Uprifosbuvir 300 mg (Capsule)
Groups C & D: Uprifosbuvir 300 mg (Tablet)
Groups C & D: Uprifosbuvir 400 mg (Capsule)
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 two weeks prior and 6-8 weeks after completion of standard of care neoadjuvant chemoradiation
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?

VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
224,706 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
67 Previous Clinical Trials
17,151 Total Patients Enrolled
Portland VA Medical CenterFED
43 Previous Clinical Trials
7,750 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
93 Previous Clinical Trials
57,924 Total Patients Enrolled
VA Boston Healthcare SystemFED
70 Previous Clinical Trials
970,487 Total Patients Enrolled
North Texas Veterans Healthcare SystemFED
38 Previous Clinical Trials
4,005,079 Total Patients Enrolled
VA Ann Arbor Healthcare SystemFED
18 Previous Clinical Trials
10,179 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,788 Total Patients Enrolled
Durham VA Health Care SystemFED
7 Previous Clinical Trials
64,819 Total Patients Enrolled
David H Wang, MD PhDPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI

Media Library

Itraconazole Clinical Trial Eligibility Overview. Trial Name: NCT05563766 — Phase 2
Gastroesophageal Junction Cancer Research Study Groups: Itraconazole
Gastroesophageal Junction Cancer Clinical Trial 2023: Itraconazole Highlights & Side Effects. Trial Name: NCT05563766 — Phase 2
Itraconazole 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563766 — Phase 2
~52 spots leftby Apr 2029
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