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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

Be older than 18 years old

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

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%

Abnormal faeces

33%

Nausea

33%

Dizziness

17%

Dry mouth

17%

Flushing

17%

Abdominal discomfort

17%

Vomiting

17%

Headache

17%

Erythema

100%

80%

60%

40%

20%

Study treatment Arm

Group A: Uprifosbuvir 150 mg (Cohort 4a)

Group F: Uprifosbuvir 300 mg (Tablet)

Groups C & D: Uprifosbuvir 250 mg (Capsule)

Group B: Uprifosbuvir 150 mg (Cohort 4b)

Group A: Placebo (Cohort 6a)

Group A: Uprifosbuvir 300 mg (Cohort 6a)

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 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Puget Sound Health Care SystemFED

65 Previous Clinical Trials

227,735 Total Patients Enrolled

Michael E. DeBakey VA Medical CenterFED

64 Previous Clinical Trials

15,710 Total Patients Enrolled

Portland VA Medical CenterFED

41 Previous Clinical Trials

7,264 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