Phase 2 Oesophageal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have previously had a scope procedure of the upper digestive tract (a camera examination of the throat, stomach, and upper intestine) that confirmed Barrett's oesophagus measuring at least 2 cm, with either low-grade cell changes, high-grade cell changes, or very early-stage oesophageal cancer, who have not yet had any treatment for this condition and are being considered for a burning/ablation procedure
• The Barrett's oesophagus diagnosis may have been made at a different hospital, as long as two pathologists (doctors who examine tissue samples) have reviewed and agreed on the diagnosis
• People aged 18 years or older
• People whose general health makes them suitable for an upper digestive tract scope procedure and endoscopic (internal camera-guided) treatment
• People whose blood test results show a healthy enough level of infection-fighting white blood cells (confirm with trial site)
• People whose blood test results show a healthy enough level of platelets, which help blood to clot (confirm with trial site)
• People whose liver function blood test results fall within acceptable ranges (confirm with trial site)
• People living with HIV who are on effective treatment and have had an undetectable amount of virus in their blood within the past 6 months
• People with a long-term hepatitis B infection whose virus levels are undetectable while on suppression treatment, where that treatment is required
• People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C and have an undetectable virus level
• People who take ongoing antiviral medication to manage herpes simplex virus (cold sores or related conditions)
• Women who could become pregnant and agree to use one or more highly effective, non-oestrogen-containing forms of contraception (such as progestin-only contraceptive pills, non-hormonal intrauterine devices, or tubal ligation) starting two months before joining the study, throughout the study, and for two months after finishing the study medication — and who agree not to donate eggs or participate in IVF during this period and for two months after finishing the study medication
• Men who agree to avoid donating sperm and to use highly effective contraception during any sexual activity with a woman who could become pregnant, for the duration of the study
• People who are able to understand the study and are willing to sign a written consent form agreeing to take part

Who may not be able to join:

• People with severe heart failure classified as New York Heart Association (NYHA) class III or IV (a medical grading system for heart failure severity — confirm with trial site)
• People with an abnormally prolonged heart electrical signal (QT interval) on a heart tracing — greater than 450 milliseconds for men or greater than 470 milliseconds for women (confirm with trial site)
• People who are currently taking part in another clinical trial involving an investigational (experimental) treatment
• People who have had an allergic reaction to itraconazole (the study drug) or to medicines that are chemically similar to it
• People with a serious uncontrolled illness, or a mental health condition or personal circumstances that would make it difficult to follow the study requirements
• Women who are pregnant, as the study drug may harm an unborn baby
• Women who are breastfeeding, as the study drug may affect a nursing infant
• People taking certain other medications that interact seriously with the study drug in a way that cannot be safely managed by stopping, switching, or adjusting the dose of that medication (the trial team will assess this individually for each person)
• People with a history of eosinophilic oesophagitis (a specific inflammatory condition of the food pipe)
• People with narrowing of the food pipe (oesophagus) severe enough to prevent the ablation treatment equipment from passing through
• People with an active or returning cancer in any part of the body other than the oesophagus
• People whose oesophageal cancer has progressed beyond the earliest stage (beyond T1a — meaning the cancer has grown deeper than the innermost lining of the food pipe)
• People with persistently very high blood pressure (a reading of 160 mmHg or above, lasting more than 24 hours)
• People taking a medication called eliglustat, as combining it with the study drug is not safe for certain people depending on how their body processes medications (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.