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:

• Adults aged 18 or older of any gender.
• People with colorectal cancer that has spread to other parts of the body, confirmed by a tissue or cell sample test.
• People whose cancer has continued to grow or spread after trying two previous lines of treatment for metastatic disease.
• People who have at least one area of cancer that can be measured on a scan, according to standard medical guidelines.
• People who are reasonably active and able to care for themselves, based on a standard medical scoring system (rated 0, 1, or 2 out of 5).
• People whose treating doctor estimates they are likely to live for at least 6 more months.
• People who are able to understand and are willing to sign a written consent form before any trial procedures begin.
• People whose bone marrow, liver, and kidney are working well enough, based on specific blood test results within acceptable ranges.
• Women who could become pregnant must have a negative blood pregnancy test taken within 7 days before starting the study drug.
• People who could father or become pregnant must agree to use reliable contraception from the time of signing the consent form until at least 2 months after the last dose of the study drug, as determined appropriate by the principal investigator.
• People who are able to swallow and keep down oral (tablet or capsule) medication.

Who may not be able to join:

• People whose blood counts fall below certain minimum levels — including low white blood cells, neutrophils, platelets, or haemoglobin — based on recent blood tests. (Note: receiving a blood transfusion just to meet these levels is not permitted.)
• People whose liver enzyme levels (AST or ALT) are too high based on blood tests, whether or not the cancer has spread to the liver.
• People with a blood albumin level below 5.8 g/dL.
• People with a total bilirubin level above 10 mg/dL.
• People with blood clotting test results (PT or INR) above 1.5 times the normal upper limit, unless they are on anticoagulant therapy and their levels fall within acceptable treatment ranges at their medical centre.
• People with creatinine or urea levels above 1.5 times the normal upper limit, or a kidney filtration rate below 50 mL/min.
• People with kidney failure requiring dialysis.
• Women who are pregnant, have a positive pregnancy test, or are breastfeeding.
• People with any other significant abnormal lab result that the investigator considers a safety concern.
• People with significant or uncontrolled heart-related problems, including irregular heartbeat, abnormally slow or fast heart rate, valve disease causing symptoms, severe heart failure (classified as Class III or IV), or unstable chest pain.
• People who have had a heart attack within the 6 months before signing the consent form.
• People with active or uncontrolled bleeding disorders.
• People currently experiencing persistent constipation, or who have had chronic constipation, bowel obstruction, or severe impacted stool within the past 6 months.
• People with a known or uncontrolled history of Hepatitis B, Hepatitis C, or HIV-1 or HIV-2.
• People who have had another (non-colorectal) cancer within the past 3 years, unless it was a low-risk cancer considered fully cured (such as certain skin cancers or non-invasive cancers, as determined by the investigator).
• People who have received a live or weakened vaccine (such as nasal flu spray, measles, mumps, rubella, or chickenpox vaccine) within the past month, or who have had close contact with someone who received one — except that standard flu vaccine given more than 21 days prior may be acceptable.
• People who have received any other experimental drug or participated in another clinical trial within the past 30 days.
• People with an active infection rated as moderate or severe based on standard medical grading.
• People with cancer that has spread to the brain or the lining of the brain and is causing symptoms.
• People with a wound, ulcer, or bone fracture that is not healing.
• People who have had major surgery or a significant injury within 28 days before starting the study drug.
• People who have previously been assigned to a treatment in this same study, as re-entry is not permitted.
• People with high blood pressure that is not controlled by medication (repeatedly above 140/90 mmHg).
• People who have had a significant bleeding event (rated Grade 3 or higher) within 4 weeks before starting the study drug.
• People who have had a blood clot event — such as a stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism — within 6 months before signing the consent form.
• People with another active or previously untreated cancer (except certain low-risk or fully cured cancers, as specified), or people whose prior cancer treatment was not completed at least 3 years before joining the trial.
• People with fluid build-up around the lungs or in the abdomen that is causing breathing difficulty rated Grade 2 or higher.
• People with a known or suspected allergy or sensitivity to any of the study drugs or their ingredients.
• People who, in the investigator's opinion, are otherwise unsuitable to participate in the trial for any reason.
• People with substance use issues, or medical, psychological, or social circumstances that could interfere with their ability to take part in the study or affect the reliability of results.

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