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 with a confirmed diagnosis of colorectal cancer (CRC) or a type of stomach/digestive tract cancer called gastric adenocarcinoma, where the cancer has spread or cannot be removed by surgery (Cohort A); or people with confirmed colorectal cancer with specific genetic features (p53 mutation with RAS mutation, or p53 mutation without RAS mutation) that has spread or cannot be removed (Cohorts B1 and B2)
• People who have already received at least one prior cancer treatment and whose cancer has either grown or who could not tolerate that treatment
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1)
• People who are generally well enough to carry out light activity and care for themselves (rated 0 or 1 on a standard health scale used in cancer trials)
• People whose life expectancy is assessed by the treating doctor as at least 3 months
• People whose blood test results meet certain minimum levels: red blood cell (haemoglobin) levels of at least 9 g/dL, white blood cell (neutrophil) count of at least 1,500/mm³, and platelet count of at least 100,000/mm³ without needing a transfusion or boosting medication
• People whose kidney function tests are within an acceptable range (confirm with trial site)
• People whose liver function tests, including bilirubin, are within an acceptable range (slightly higher limits may apply if cancer has spread to the liver)
• People whose blood protein (albumin) level is above 3 g/dL
• People who are able to swallow oral (tablet) medications
• People of childbearing potential who agree to use adequate contraception throughout the study, and who agree to notify their treating doctor immediately if pregnancy occurs or is suspected
• People who understand the nature of the trial and are willing to sign a written consent form approved by an ethics committee before any study-related procedures begin

Who may not be able to join:

• People who have received systemic cancer treatment within 2 weeks before the start of the trial (or within 6 weeks if that treatment was mitomycin C or a nitrosourea-type drug)
• People who have had radiotherapy within the past 2 weeks, except for palliative radiotherapy directed at painful bone areas
• People who have previously been treated with a PARP inhibitor, FUDR, or the drug combination FTD/TPI
• People with any condition that the trial doctor believes may prevent proper absorption of the study medications through the digestive system
• People who have had a blockage or perforation (tear) of the bowel without surgical diversion within 4 weeks before the trial start date
• People with severe fluid build-up in the abdomen that requires drainage once a week or more often, or who have a permanent drainage catheter in place
• People with untreated cancer that has spread to the brain or spinal cord; people with a specific type of cancer spread called leptomeningeal disease are also not eligible; however, people with brain metastases that have been treated and have been stable for at least 4 weeks may be considered
• People who have had a serious heart or blood vessel event in the past 3 months, including severe heart failure, heart attack, stroke, blood clots in the lungs or legs, or serious abnormal heart rhythms
• People who have another cancer that currently requires active treatment
• People who still have side effects from previous cancer treatment that are rated as moderate or severe (grade 2 or higher)
• People with an active infection that is currently being treated with antibiotics
• People with a known HIV infection, active hepatitis B infection, or untreated hepatitis C infection; people with hepatitis C that has been successfully treated and whose viral load is undetectable may be considered
• People with any history of a bone marrow disorder (myelodysplastic syndrome), acute leukaemia, or a bone marrow transplant
• People who are pregnant or currently breastfeeding
• People who are unwilling or unable to follow the requirements of the trial
• People whom the trial doctor considers unsuitable to receive the study medication for any reason

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