Phase 2 Colorectal 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 been diagnosed with colorectal cancer (cancer of the colon and/or rectum) that has spread to other parts of the body, confirmed by laboratory testing of tissue samples.
• People whose tumor has a specific genetic feature called MGMT promoter methylation (confirmed by a specific test showing more than 5%) and no MGMT protein expression, as confirmed by tissue testing.
• People whose tumor has been tested and shown to have a specific DNA repair status known as pMMR or MSS (confirm with trial site for what this means for your situation).
• People who have given written agreement to take part before any study procedures begin.
• People who have stored tumor tissue available (from either the original tumor, spread sites, or at least one of these) for further testing.
• People who can provide a blood sample for research testing.
• People whose colorectal cancer has spread but has not yet been treated with chemotherapy for the metastatic (spread) stage of the disease.
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines.
• People aged 18 to 75 years old.
• People who are generally well enough to carry out daily activities — those under 70 must meet a certain fitness level (ECOG score of 0 or 1), and those aged 70–75 must be at the highest fitness level (ECOG score of 0) (confirm with trial site).
• People who are expected to live for at least 12 weeks.
• People who previously received certain chemotherapy treatments before their cancer spread, provided that treatment ended more than 6 months before the cancer came back.
• People whose blood counts and organ function fall within acceptable ranges — including white blood cells, platelets, and haemoglobin levels, as well as liver and kidney function tests.
• Women who could become pregnant must have a negative blood pregnancy test before starting the trial.
• All participants who could father or carry a child must be willing to use reliable contraception from the screening visit through to 6 months after the last treatment dose.
• People who are willing and able to follow the trial procedures as required.
• People who have stored tumor tissue (in a specific format called FFPE) available for testing — or, if the tissue block is not available, at least 25 very thin tissue slices prepared in a specific way.

Who may not be able to join:

• People who need to take other medications that would interfere with the trial drugs, affect their ability to follow the treatment plan, or put them at high risk of serious side effects.
• People whose cancer that has spread may be fully removable by surgery, as assessed by a specialist medical team.
• People who have had radiotherapy anywhere on their body within 4 weeks before joining the trial.
• People who carry certain specific genetic variations in a gene called DPYD, which affects how the body processes certain chemotherapy drugs (confirm with trial site for the specific variants).
• People who carry certain specific genetic variations in a gene called UGT1A1 that affect how the body processes certain drugs (confirm with trial site for the specific variants).
• People who have untreated cancer that has spread to the brain or spinal cord, or who have a history of brain metastases (cancer spread to the brain).
• People with a history or current signs of disease affecting the central nervous system (brain and spinal cord) that has not been adequately treated.
• People with active, uncontrolled infections or other serious ongoing illnesses that would make chemotherapy unsafe.
• People with known problems with blood clotting or unusual bleeding.
• People with high blood pressure that is not controlled, or a history of a severe high blood pressure crisis affecting the brain.
• People who have had a significant heart or blood vessel event in the past 6 months — such as a stroke, heart attack, unstable chest pain, moderate to severe heart failure, or a serious irregular heartbeat requiring medication.
• People with significant problems with major blood vessels (such as a large aortic aneurysm or a blood clot in an artery) within the past 6 months.
• People who have had a severe blood clot in a vein (rated Grade 4 or above on a standard medical scale).
• People who have had a bowel or stomach perforation, an internal abdominal abscess, an abnormal passage (fistula) in the abdomen, or active gastrointestinal bleeding within 6 months before the first treatment.
• People who have taken part in another clinical trial or received an experimental treatment within 30 days before joining (or longer, depending on the experimental drug).
• People who have or have had another cancer in the past 3 years, with the exception of certain skin cancers or early-stage cervical cancer that has been treated locally.
• People who cannot swallow or absorb oral (by mouth) medication properly due to problems with the upper digestive tract.
• People with a known allergy or sensitivity to any of the trial drugs or their ingredients.
• People who need to take other medications that are known to be unsafe to use alongside the trial drugs.
• Women who are pregnant or breastfeeding.

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