Phase 4 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 given written or electronic consent to take part.
• Adults aged 18 years or older, of any gender.
• People who have been diagnosed with colorectal cancer that has spread (metastatic colorectal adenocarcinoma), confirmed by a tissue or cell sample, with a documented RAS gene status.
• People who have already received standard approved treatments, including: chemotherapy containing fluoropyrimidine, oxaliplatin, and irinotecan; a type of targeted therapy that blocks blood vessel growth (anti-VEGF therapy, such as bevacizumab, aflibercept, or ramucirumab); and, if the tumour type and health conditions make it appropriate, anti-EGFR therapy (such as cetuximab or panitumumab) for those with a RAS wild-type tumour, and/or a PD-1 inhibitor for those whose tumour is identified as MSI-H or dMMR (confirm with trial site for specific requirements).
• People who identify as Black and/or African American, or Hispanic and/or Latino, or both.
• People who weigh at least 40 kilograms.
• People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only).
• People whose cancer can be measured using standard imaging methods.
• People who are able to use highly effective contraception throughout the trial and for 2 weeks after the last dose, if there is any possibility of becoming pregnant or fathering a child (confirm with trial site for accepted methods).

Who may not be able to join:

• People whose blood test results show low white blood cell counts, low platelet counts, or low haemoglobin levels — including those who received a blood transfusion in the week before enrolment specifically to try to meet these thresholds.
• People with elevated bilirubin levels in the blood above a certain threshold (those with a previously documented condition called Gilbert syndrome may still be considered if levels are within a specified range — confirm with trial site).
• People with liver enzyme levels (ALT or AST) that are too high, based on whether or not the cancer has spread to the liver.
• People with poor kidney function, measured by how well the kidneys filter waste from the blood.
• People with too much protein in their urine, confirmed by urine testing.
• People with uncontrolled high blood pressure, despite receiving treatment for it.
• People with certain abnormal blood clotting test results, unless they are already taking blood-thinning medication for preventive purposes.
• People with a history of or currently active stomach or bowel ulcers, ulcerative colitis, active bleeding from a bowel tumour, a history of bowel perforation or abnormal connections (fistulas), or any other condition that the doctor believes could lead to serious bowel bleeding or perforation within the 6 months before screening.
• People who have had bleeding from any other part of the body (such as coughing or vomiting blood) within 2 months before screening.
• People who have had a blood clot in a deep vein, in the lungs, or in an artery within 6 months before screening.
• People who have had a stroke or a mini-stroke (transient ischaemic attack) within 12 months before screening.
• People with significant heart problems, such as a recent heart attack, bypass surgery, severe chest pain, serious heart failure, dangerous heart rhythm problems, or reduced heart pumping function — within 6 months before enrolment.
• People with certain heart electrical abnormalities (a prolonged QT interval on a heart tracing), or risk factors for this, such as low potassium levels, or a personal or family history of a condition called long QT syndrome.
• People who have received cancer treatments (such as chemotherapy, radiotherapy, hormone therapy, or immunotherapy) or any experimental therapy within 2 weeks before the first dose of the trial treatment.
• People who have taken certain targeted cancer medicines (small molecule therapies, such as tyrosine kinase inhibitors) within 4 weeks or 5 half-lives of the medicine (whichever is shorter) before the first trial dose.
• People who have received radiotherapy to bone for pain relief within 2 weeks before starting the trial treatment.
• People who have received a type of internal radiation therapy (brachytherapy, where radioactive seeds are implanted) within 60 days before the first trial dose.
• People who have had surgery or an invasive procedure (including a biopsy) within 14 days before the first trial dose, or who have a surgical wound that has not fully healed.
• People who still have significant side effects from previous cancer treatments (above a mild level), except for hair loss or mild-to-moderate nerve-related side effects.
• People with a known HIV infection.
• People with a known history of active viral hepatitis, unless hepatitis B is undetectable on appropriate treatment, or hepatitis C is undetectable while currently on treatment.
• People with a serious active infection that requires antibiotics given through a drip (intravenously).
• People whose tumour is growing into or pressing on a major blood vessel (such as a large artery or vein).
• People who are currently pregnant or breastfeeding.
• People with cancer that has spread to the brain or spinal cord that has not been treated with surgery or radiotherapy, or where there is no evidence of stable disease on imaging for at least 14 days; also excluded are those who have needed steroid medicines within 4 weeks before starting the trial.
• People who have had another type of cancer in the past 5 years, with some exceptions (such as certain treated skin cancers or early-stage cervical or bladder cancers — confirm with trial site).
• People who are unable to swallow tablets, have difficulty swallowing, or have a stomach or bowel condition that may affect how the trial medicine is absorbed.
• People with any other illness, disorder, or condition that the doctor believes could make the trial medicine unsafe, affect the trial results, or put the person at undue risk.
• People with a known allergy to the trial medicine (fruquintinib) or any of its ingredients, including certain yellow food dye components (Tartrazine/FD&C Yellow 5 and Sunset Yellow/FD&C Yellow 6).
• People who have previously been treated with fruquintinib.
• People who have received a live vaccine within 28 days before the first trial dose (standard flu shots are generally allowed, but nasal spray flu vaccines are not).
• People who have taken certain medicines that strongly affect how the body processes the trial drug (strong CYP3A4 inducers) within 2 weeks before the first dose.

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