Barrett Oesophagitis With DysplasiaEarly Phase 1NCT05609253
Itraconazole to Prevent Recurrent Barrett's Esophagus
A Early Phase 1 study testing Itraconazole in capsule form and Itraconazole in solution form in people with Barrett Oesophagitis With Dysplasia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Oesophagitis With Dysplasia
- What is being tested?
- Itraconazole in capsule form and Itraconazole in solution form
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Who cannot join
- Inability to provide informed consent, New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (>450 ms for men and QTc>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation
Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure
- Conditions
- Barrett Oesophagitis With Dysplasia
- Being tested
- Itraconazole in capsule form, Itraconazole in solution form
- Keywords
- Barrett's esophagus
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole in capsule formDrug
Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5).
Itraconazole in solution formDrug
Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5).
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole in capsule form | Active comparator | Participants in this arm will receive the capsule form of itraconazole Receives: Drug: Itraconazole in capsule form |
| Itraconazole in solution form | Active comparator | Participants in this arm will receive the solution form of itraconazole Receives: Drug: Itraconazole in solution form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Itraconazole drug and blood levels
The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.
Measured: 8-12 months after study initiation
Secondary outcomes (5)
Safety and tolerability of itraconazole
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 8-12 months after study initiation
Effects of itraconazole on Gli1 expression
Reduction in Gli1 expression
Measured: 8-12 months after study initiation
Effects of itraconazole on (Patched) PTCH expression
Reduction in PTCH expression by IHC
Measured: 8-12 months after study initiation
Effects of itraconazole on AKT pathway
Reduction in Phospho S6 by IHC
Measured: 8-12 months after study initiation
Effects of itraconazole on angiogenesis
Reduction in Vascular endothelial growth factor (VEGF)/ Vascular endothelial growth factor receptor type 2 (VEGFR2) by IHC
Measured: 8-12 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start14 Sep 2022
- Primary completion23 Feb 2024
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett Oesophagitis With DysplasiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The primary purpose is to determine the ideal formulation (capsule versus solution) of itraconazole in this short-term pilot study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609253
- Sponsor's protocol ID
- 00148341
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation
- ClinicalTrials.gov ID
- NCT05609253
- Acronym / sponsor ID
- 00148341
- Conditions
- Barrett Oesophagitis With Dysplasia
- Keywords
- Barrett's esophagus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Texas, Southwestern Medical Center at Dallas
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary purpose is to determine the ideal formulation (capsule versus solution) of itraconazole in this short-term pilot study.
| Arm | Type | Receives |
|---|---|---|
| Itraconazole in capsule form | Active comparator | Drug: Itraconazole in capsule formParticipants in this arm will receive the capsule form of itraconazole |
| Itraconazole in solution form | Active comparator | Drug: Itraconazole in solution formParticipants in this arm will receive the solution form of itraconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (1 listed)
- Inability to provide informed consent, New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (>450 ms for men and QTc>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itraconazole in capsule formPatients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5). | Drug | Itraconazole in capsule form |
| Itraconazole in solution formPatients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5). | Drug | Itraconazole in solution form |
Primary outcome
Itraconazole drug and blood levels
Time frame: 8-12 months after study initiation
The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.
5 secondary outcomes
Safety and tolerability of itraconazole
Time frame: 8-12 months after study initiation
Effects of itraconazole on Gli1 expression
Time frame: 8-12 months after study initiation
Effects of itraconazole on (Patched) PTCH expression
Time frame: 8-12 months after study initiation
Effects of itraconazole on AKT pathway
Time frame: 8-12 months after study initiation
Effects of itraconazole on angiogenesis
Time frame: 8-12 months after study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Itraconazole in capsule form and Itraconazole in solution form in people with Barrett Oesophagitis With Dysplasia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itraconazole drug and blood levels (time frame: 8-12 months after study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.