Phase 2 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 have been diagnosed with colorectal cancer that has spread to other parts of the body, confirmed by laboratory testing of tissue or cell samples, with previous test results on file for certain genetic and protein markers (RAS, BRAF, MSI/MMR, and HER2).
• People whose cancer has continued to grow or who could not tolerate certain previous treatments, including fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy; anti-VEGF therapies such as bevacizumab, aflibercept, or ramucirumab; and, for those without a specific RAS gene mutation, anti-EGFR therapies such as cetuximab or panitumumab — where these treatments were not medically unsuitable.
• People who have measurable or detectable disease visible on a CT, MRI, or PET scan, as assessed by the trial doctor.
• People who weigh at least 40 kg (approximately 88 pounds).
• People aged 22 years or older.
• People who are able to understand a written consent form and are willing to sign it.
• People with a general physical functioning level rated 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site).
• People whose blood tests show the heart, liver, kidneys, and bone marrow are working adequately within 14 days before starting treatment (confirm with trial site for specific values).
• People who are expected to live longer than 12 weeks, as determined by the trial doctor.
• People of childbearing potential who agree to avoid becoming pregnant from the start of treatment until at least 14 days after the last dose; and male participants who agree to avoid causing a pregnancy during the same period, as the study drug may harm an unborn baby.

Who may not be able to join:

• People with high blood pressure that is not adequately controlled, as judged by the trial doctor.
• People with a history or current presence of stomach or bowel ulcers, ulcerative colitis, bleeding from an unremoved bowel tumour, bowel perforation, abnormal connections between organs (fistulas), or any similar condition the doctor believes could lead to serious gastrointestinal bleeding or perforation.
• People who have had bleeding from any site in the body — such as the lower bowel, coughing up blood, or vomiting blood — within the two months before screening.
• People who have had a blood clot in a vein or artery (such as a deep vein thrombosis or pulmonary embolism) within the three months before screening, unless they are on a stable blood-thinning medication and recent scans show no active clots; people who have had a severe, large pulmonary embolism requiring surgical or clot-dissolving treatment within the 12 months before screening are also excluded.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within the 12 months before screening.
• People with serious heart conditions, including a heart attack or heart bypass surgery within the past six months, severe or unstable chest pain (angina), advanced heart failure (Class III or IV), dangerous heart rhythm problems requiring treatment, or a previously recorded low heart pumping function below 50%.
• People with a specific type of irregular heart electrical activity on testing (QTcF greater than 480 milliseconds), or factors that raise the risk of dangerous heart rhythm problems, including low potassium levels, a personal or close family history of long QT syndrome, or an unexplained sudden death in a first-degree family member under age 40.
• People currently taking medications known to cause dangerous heart rhythm problems (a continually updated list is available at www.crediblemeds.org).
• People who have received systemic cancer treatments — including chemotherapy, biological therapy, or immunotherapy — within four weeks before the first dose of the study drug (palliative radiation to some areas may be permitted).
• People who have taken targeted cancer therapy tablets or capsules (such as tyrosine kinase inhibitors) within five half-lives or four weeks of the first dose, whichever is the shorter period.
• People who have had major surgery within 30 days before the first dose, or who have a surgical wound that has not yet fully healed.
• People who still have side effects from previous cancer treatment that are rated above a moderate level (greater than Grade 2) on a standard medical scale.
• People with a current problem with drug or alcohol misuse.
• People living with HIV whose virus levels or immune cell counts are not well controlled with anti-HIV medication.
• People with a known history of active viral hepatitis; people with chronic hepatitis B must have an undetectable virus level on appropriate suppressive treatment; people with hepatitis C who are currently being treated may be eligible if their virus level is undetectable (confirm with trial site).
• People with a serious active infection that requires intravenous (IV) antibiotics.
• People whose tumour has grown into a major blood vessel, such as the pulmonary artery or the large veins that carry blood to and from the heart.
• People with cancer that has spread to the brain or spinal cord that has not been treated with surgery or radiation, or where scans have not shown stable disease for at least 14 days.
• People with another currently active cancer, unless the trial doctor believes it is unlikely to affect the safety of the participant or the trial results.
• People who are unable to swallow oral medication, including those with difficulty swallowing, an altered stomach from previous surgery such as gastric bypass, severe bowel disease, or any other condition the trial doctor believes may prevent proper absorption of the study drug.
• People with a metabolic disorder that the trial doctor believes may interfere with how the study drug works, affect the trial results, or put the participant at unnecessary risk.
• People who have previously been treated with fruquintinib (one of the study drugs).
• People with a known allergy to fruquintinib or any of its ingredients, including the colouring agents tartrazine, FD&C Yellow 5, or sunset yellow FCF.
• People currently taking strong medications that significantly speed up or slow down the breakdown of certain drugs by the liver (strong CYP3A4 inducers or inhibitors) within five half-lives or four weeks before the first dose, whichever is longer (a full list of these medications is available from the trial site).
• People currently taking any other experimental study drugs.
• People with active soreness, ulcers, or other problems inside the mouth that could interfere with the use of a medical device used in this trial (the TheraBionic P1), such as mouth ulcers, thrush, oral herpes, or gum inflammation.
• People taking calcium channel blocker medications or certain other drugs that block specific calcium channels (for example amlodipine, nifedipine, ethosuximide, or high-dose vitamin C), unless these are stopped at least 7 days before starting treatment with the TheraBionic P1 device; participants must also agree not to use these medications for the entire duration of the study (a full list is available from the trial site).
• People who are pregnant or currently breastfeeding; breastfeeding must be stopped before participation would be considered.
• People who have received a live vaccine within 28 days before the first dose of fruquintinib (standard inactivated flu vaccines are generally permitted; nasal spray flu vaccines are not).
• People who are unwilling to follow the study protocol, or who have a physical or cognitive condition that would prevent them from using the study device.

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