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Itraconazole for Esophageal Cancer
Phase 2
Recruiting
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
Patients diagnosed with localized (locoregional) esophageal cancer
Patients diagnosed with localized (locoregional) gastroesophageal junction cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 months
Awards & highlights
Study Summary
This trial is testing whether the anti-fungal drug itraconazole can help treat esophageal cancer when used alongside standard chemoradiation therapy.
Who is the study for?
This trial is for individuals with localized esophageal or gastroesophageal junction cancer. Participants must be able to consent, have normal heart rhythm (QTc ≤450ms), no severe heart failure history, liver function tests within three times the upper limit of normal, and not be pregnant or allergic to itraconazole.Check my eligibility
What is being tested?
The study is testing if Itraconazole can improve outcomes when given before standard chemoradiation therapy in treating esophageal and gastroesophageal junction cancers. It's a phase II trial focusing on how this anti-fungal drug affects cancer pathways.See study design
What are the potential side effects?
Itraconazole may cause side effects like nausea, rash, liver problems, heart issues such as congestive heart failure or abnormal heartbeat (QT prolongation), and could potentially interact with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My esophageal cancer has not spread beyond the local area.
Select...
My cancer is located at the junction of the stomach and esophagus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of pathological complete response with itraconazole
Secondary outcome measures
Comparison of hedgehog biomarkers before and after intervention
Comparison of phosphorylated VEGFR2 and AKT before and after intervention
Levels of itraconazole and metabolites in esophageal tissue
Side effects data
From 2015 Phase 1 & 2 trial • 178 Patients • NCT0197468733%
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%
0%
Study treatment Arm
Group A: Uprifosbuvir 150 mg (Cohort 4a)
Group B: Uprifosbuvir 150 mg (Cohort 4b)
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 capsule 300mg twice daily for 6-8 weeks following chemoradation.
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
4,757 Total Patients Enrolled
David Wang, MD, PhDPrincipal Investigator - North Texas Veterans Healthcare System
VA North Texas Health Care System-Dallas VA Medical Center
Vanderbilt University School Of Medicine (Medical School)
Johns Hopkins University School Medicine (Residency)
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My esophageal cancer has not spread beyond the local area.My cancer is located at the junction of the stomach and esophagus.You are allergic to itraconazole.I have had heart failure symptoms in the past.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Itraconazole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given its okay to use Itraconazole?
"While there is some data surrounding Itraconazole's safety, as this is only a Phase 2 trial, there is not yet any information regarding its efficacy."
Answered by AI
How many people can join the trial at most?
"According to the listing on clinicaltrials.gov, this trial is still open and actively recruiting patients. The study was first posted on June 24th, 2019, with the most recent update being November 2nd, 2021. They are looking for a total of 78 participants across 1 location."
Answered by AI
Are there any positions open for volunteers in this research?
"This particular clinical trial, which was first announced on June 24th, 2019, is looking for test subjects. The information regarding the study has been updated as recently as November 2nd, 2021."
Answered by AI
Have there been other similar trials to this one previously?
"Itraconazole has been clinically studied since 2014, when the first Phase 1 trial was sponsored by AstraZeneca. After this initial study of 39 people in 2014, Itraconazole received approval as a Phase 1 drug. As of now, there are 16 active studies involving Itraconazole in 43 cities and 14 countries."
Answered by AI
What are the most frequent conditions that Itraconazole is used to treat?
"chromomycosis can be cured with Itraconazole. This medication is also able to treat other fungal infections like vulvovaginal candidiasis, dermatomycoses, and disseminated other specified protozoal diseases."
Answered by AI
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