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Itraconazole for Esophageal Cancer

Phase 2
Waitlist Available
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
Capable of giving informed consent
World Health Organization (WHO)/ECOG performance status (PS) of 0-2 at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can agree to participate.
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I can take care of myself and perform daily activities.
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I have been diagnosed with esophageal or GEJ cancer and am planned for surgery after chemotherapy and radiation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Itraconazole
Secondary outcome measures
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
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 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
~780

Find a Location

Who is running the clinical trial?

VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,714 Total Patients Enrolled
Portland VA Medical CenterFED
41 Previous Clinical Trials
7,287 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,710 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a few places in the state where this research is being conducted?

"Currently, patients are being recruited from the Durham VA Medical Center in North carolina, the VA Puget Sound Health Care System in Seattle, Washington, and the VA North Texas Health Care System in Dallas, Texas. There are also 6 other recruitment sites."

Answered by AI

Are patients being recruited for this study at the current time?

"This study, as detailed on clinicaltrials.gov, is not recruiting patients at this time. The trial was initially posted on December 15th, 2022 and was last updated September 28th, 2022. Although this particular study isn't looking for participants, there are 2,824 other studies that are presently open for enrollment."

Answered by AI

What are the common side effects of Itraconazole?

"While itraconazole has not been proven effective in clinical trials, there is evidence that it is safe. We have given it a score of 2."

Answered by AI
~52 spots leftby Apr 2029