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Prevention study for Barrett Esophagus
Official title Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus
ClinicalTrials.gov ID: NCT06732388
What this study is testing
What is Itraconazole?
Itraconazole is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for barrett esophagus.
Also referred to as Lozanoc, Oriconazole.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD)...
- Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two...
- Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \< 18 years of age...
- Clinically eligible for EGD and endoscopic treatment of BE
- Absolute neutrophil count ≥ 1,000/microliter
You likely can't join if
- Current New York Heart Association (NYHA) class III or IV congestive heart failure
- Prolonged corrected QT (QTc) (\> 450 ms for men and \> 470 ms for women)
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole
- Uncontrolled intercurrent illness., or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects...
See the full eligibility criteria
- Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC)...
- Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the...
- Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \< 18 years of age, children are excluded from this study
- Clinically eligible for EGD and endoscopic treatment of BE
- Absolute neutrophil count ≥ 1,000/microliter
- Platelets ≥ 100,000/microliter
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
- Note: Higher total bilirubin levels (≤ 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 1.5 × institutional upper limit of normal
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
- There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing...
- Activities of Reproductive Potential: In addition to heterosexual intercourse, activities that could lead to pregnancy (e.g. sperm or egg donation, participation in in vitro fertilization) should be considered when...
- Females of Reproductive Potential: A non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure. A female who has had a tubal ligation sterilization, or hysterectomy...
- Menopause:
- Twelve (12) months of spontaneous amenorrhea or;
- Spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL or;
- Subject is post-bilateral oophorectomy with or without hysterectomy
- Ability to understand and the willingness to sign a written informed consent document
- Current New York Heart Association (NYHA) class III or IV congestive heart failure
- Prolonged corrected QT (QTc) (\> 450 ms for men and \> 470 ms for women)
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole
- Uncontrolled intercurrent illness., or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in...
- Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a...
- Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management...
- History of eosinophilic esophagitis
- History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly
- Participants must not have evidence of active/recurrent invasive cancer of a non-esophageal organ
- Participants with EAC greater than stage T1a
- Persistent (\> 24 hour [h]) systolic blood pressure (BP) greater than or equal to 160 mmHg (to avoid reaching hypertensive crisis defined as systolic BP \> 180 mmHg)
- Patients taking eliglustat. Co-administration of itraconazole and eliglustat is contraindicated in people that are poor or intermediate metabolizers of CYP2D6
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Chapel Hill, North Carolina, United States; Cleveland, Ohio, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.