Phase 3 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 aged 18 to 70 years old at the time of signing the consent form
• People who have been diagnosed with colorectal cancer that has spread to other parts of the body (metastatic), confirmed by a tissue or cell sample
• People whose cancer has a specific genetic change called BRAFV600E (or BRAFV600), detected by a lab test at any point before the screening stage
• People who are able to provide a tumour tissue sample (either previously stored or newly collected) for testing at a central laboratory
• People whose cancer has continued to grow or spread after at least one previous treatment for metastatic disease
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines (RECIST 1.1)
• People with a good general level of physical function, rated 0 or 1 on a standard scale used by doctors (ECOG Performance Status)
• People with a life expectancy of at least 3 months
• People who are able to swallow oral medication
• People with adequate blood, kidney, heart, and liver function, confirmed by lab tests done within 7 days before starting treatment
• People who are willing and able to attend all required study visits and follow-up appointments
• People who have provided written informed consent before any study procedures begin

Who may not be able to join:

• People who have previously been treated with a BRAF inhibitor or MEK inhibitor
• People who have a known medical reason why they cannot receive the comparison treatment used in this trial (confirm with trial site)
• People with brain metastases or cancer affecting the lining of the brain or spinal cord that are causing symptoms
• People with a history of chronic inflammatory bowel disease or Crohn's disease that required medication or surgery within the 12 months before joining the trial
• People with a known history of acute or chronic inflammation of the pancreas (pancreatitis)
• People with uncontrolled gastrointestinal bleeding, difficulty swallowing, persistent nausea or vomiting, prior removal of part of the small bowel, or any other gut condition that could prevent the study medication from being properly absorbed
• People who have had serious heart or blood vessel problems in the 6 months before starting the trial, including uncontrolled heart failure, uncontrolled high blood pressure, reduced blood flow to the heart, heart attack, severe irregular heartbeat, blood clots in the legs or lungs, or a stroke
• People with a history of, or current risk factors for, a blockage of the vein at the back of the eye (retinal vein occlusion), such as uncontrolled glaucoma or a history of abnormal blood thickness or clotting conditions
• People with an ongoing muscle or nerve disorder that is associated with raised levels of a muscle enzyme called creatine kinase (for example, muscular dystrophy, ALS, or inflammatory muscle disease)
• People with high blood pressure that cannot be controlled with medication
• People who have had another cancer within the past 5 years, except for certain low-risk or fully treated cancers such as basal or squamous cell skin cancer, superficial bladder cancer, early prostate changes, cervical carcinoma in situ, or other non-invasive slow-growing cancers
• People who still have side effects rated grade 2 or higher (on a standard medical scale) from a previous cancer treatment, except for grade 2 hair loss or grade 2 nerve-related symptoms
• People who are HIV positive, have a positive test for syphilis (Anti-TP), or have an active hepatitis B or hepatitis C infection

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