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 are willing and able to sign and date a consent form.
• People who are able to follow all study procedures and remain available for the full duration of the trial, as judged by the study doctor.
• People aged 18 or older.
• People who are generally well enough to carry out all normal daily activities, or who are restricted in strenuous activity but can still walk and do light work (this is measured using a standard scale called ECOG, with a score of 0 or 1 required).
• People who have been diagnosed with advanced or metastatic colorectal cancer (cancer of the colon or rectum that has spread), confirmed by a tissue or cell sample.
• People who have previously been treated with specific standard chemotherapy and targeted drugs for advanced or metastatic colorectal cancer — including fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab (unless not suitable for them), and cetuximab or panitumumab (for those whose tumour has a normal RAS gene) — and whose cancer has since progressed or who could not tolerate their last treatment. (There are specific rules about how prior treatments count; confirm details with the trial site.)
• People whose tumour has been tested and confirmed to have a normal mismatch repair system (called MMRp), meaning the tumour is not a type called MSI-high.
• People whose tumour has been tested for RAS and BRAF gene changes, with results documented.
• People who have measurable disease, meaning at least one tumour that can be measured on a scan according to standard criteria (called RECIST v1.1).
• People who are able to swallow and absorb oral (by mouth) medication.
• People whose blood counts and organ function meet specific minimum standards on tests taken within 72 hours before starting the trial drug (confirm exact values with the trial site).
• Women who could become pregnant must agree to use highly effective contraception (with a failure rate of less than 1% per year) or remain abstinent during treatment and for at least 180 days after the last dose of study treatment. Certain methods such as periodic abstinence and withdrawal are not accepted. (Confirm acceptable methods with the trial site.)
• Men with female partners who could become pregnant, or who are pregnant, must agree to use a condom or remain abstinent during treatment and for at least 180 days after the last dose, and must not donate sperm during this time.

Who may not be able to join:

• People whose tumour is known to be MSI-high or mismatch repair deficient (dMMR), or people for whom this status is completely unknown.
• People whose tumour has a BRAF V600 mutation.
• People who have previously been treated with regorafenib, trifluridine-tipiracil (TAS-102), or fruquintinib.
• People who have had major surgery within 14 days before the first dose of study treatment (minor procedures such as biopsies are not included in this rule).
• People who have not yet recovered from significant side effects of their most recent cancer treatment.
• People who have untreated cancer spread to the brain or spinal fluid. People with treated brain metastases may be considered eligible if there has been no sign of progression for at least 4 weeks after brain-directed treatment, confirmed by imaging. (Confirm with trial site.)
• People with another current or past cancer that could interfere with the safety or results of this trial, as judged by the study doctor.
• People with certain serious uncontrolled medical conditions, including but not limited to: fluid build-up around the lungs, heart, or abdomen requiring repeated drainage; uncontrolled heart rhythm problems; uncontrolled high blood pressure despite maximum medication; significant protein in the urine; moderate to severe heart failure or reduced heart pumping function; severe or unstable chest pain (angina) within the past 3 months; active serious infection requiring intravenous antibiotics within 1 week before starting treatment; or certain abnormalities in a heart electrical reading (QT interval) that increase the risk of dangerous heart rhythms.
• People with a history of, or currently active, stomach or intestinal ulcers, ulcerative colitis, recent bowel blockage, perforation, or fistula, or any condition the study doctor believes could cause serious gastrointestinal bleeding or perforation, within 6 months before starting treatment.
• People who have had bleeding from any site (such as coughing or vomiting blood) within 3 months before starting treatment.
• People who have had a blood clot in a vein (such as a deep vein thrombosis or pulmonary embolism) within 3 months before starting treatment.
• People who have had a blood clot in an artery (such as a stroke, mini-stroke, heart attack, or coronary bypass surgery) within 6 months before starting treatment.
• People whose cancer has grown into a major blood vessel (such as a large artery or vein).
• People who are unable to stop taking medications known to cause dangerous heart rhythm changes (QT prolongation) at least 7 days before starting treatment.
• People taking certain medications that strongly affect how the body processes drugs (strong or moderate CYP3A inducers) within 7 days before starting treatment (confirm with trial site).
• People with AIDS. People living with HIV who are on effective treatment and have an undetectable viral load may be considered eligible.
• People with chronic hepatitis B whose viral load is not undetectable on suppressive therapy, or people with hepatitis C who have not been successfully treated and cured, or who are on current hepatitis C treatment without an undetectable viral load.
• People with a recent COVID-19 diagnosis, whether or not they had symptoms, unless specific recovery conditions have been met (confirm exact requirements with the trial site).
• People with a history of severe allergic reactions to any of the study medications.
• People who are unable to swallow, keep down, or absorb oral medications.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with other serious uncontrolled medical or psychiatric conditions that, in the study doctor's opinion, would affect their ability to participate in or complete the trial.

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