Phase 1 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 are considered high risk for recurring colorectal polyps (adenomas), meaning they have been diagnosed with Familial Adenomatous Polyposis (FAP), OR had more than 5 small polyps (under 1 cm) found on a colonoscopy in the past 5 years, OR had 3 or more polyps with at least one being 1 cm or larger on a recent colonoscopy
• People aged 18 or older at the time of signing the consent form
• People who are generally well enough to carry out daily activities with little or no limitation (confirm with trial site)
• People whose blood cell counts fall within acceptable ranges — including white blood cells, neutrophils (infection-fighting cells), and platelets (confirm with trial site)
• People whose liver function and kidney function test results are within acceptable ranges (confirm with trial site)
• People who are scheduled for a routine colonoscopy to check for and remove polyps, where at least two polyps of 5 mm or larger are found, including at least one in the lower part of the bowel that can be left in place and marked for follow-up
• People who are willing to have a second, research-related bowel examination (either a shorter scope procedure or full colonoscopy) about 12 weeks after starting the study treatment
• People who are willing and able to attend all scheduled visits, follow testing schedules, and complete all study requirements
• People with a life expectancy of at least 5 years
• People of childbearing potential who agree to use effective contraception before, during, and for four weeks after the study treatment ends
• People who are able to understand the study and are willing to sign a written consent form

Who may not be able to join:

• People with a personal history of Lynch syndrome (also called hereditary nonpolyposis colorectal cancer, or HNPCC)
• People who are currently taking part in another clinical trial, or who have received an experimental treatment within the past four weeks
• People with a prior history of invasive colorectal cancer
• People who have had another type of invasive cancer that is still active or being treated within the past 3 years (some exceptions may apply, such as certain treated skin cancers or cervical pre-cancers — confirm with trial site)
• People who have previously received chemotherapy or the study drug ONC201
• People who have had an allergic reaction to drugs chemically similar to ONC201
• People with uncontrolled ongoing illness, including active infection, certain heart conditions, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People who are pregnant or currently breastfeeding
• People who are taking certain medications that strongly affect how the body processes drugs (known as CYP3A4/5 inducers or inhibitors) and are unable to stop those medications at least 72 hours before starting the study drug (confirm with trial site)
• People whose heart electrical activity shows a prolonged QT interval on a heart tracing (ECG) taken during screening, or who have a personal or family history of certain heart rhythm problems (confirm with trial site)
• People taking medications known to affect heart rhythm in a particular way (QT prolongation with risk of torsade de pointes) who are unwilling or unable to switch to an alternative medication at least 72 hours before starting the study drug

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