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 aged 18 or older
• People who have a confirmed diagnosis of colorectal cancer (adenocarcinoma type), confirmed through a tissue or cell sample
• People who have scans showing the cancer has spread to other parts of the body (metastatic disease)
• People whose cancer can be measured on scans according to standard research criteria (RECIST 1.1)
• People whose tumor has tested positive for a specific gene change called BRAF V600E, confirmed by a PCR or gene sequencing (NGS) test at any point before entering the study
• People whose cancer got worse while receiving a specific combination treatment (encorafenib plus cetuximab, referred to as "EC") given as a second-line treatment
• People whose best response to the EC treatment was that the cancer shrank (complete or partial response) or stayed stable for at least 3 months
• People who are considered well enough by their doctor to receive a chemotherapy regimen called FOLFIRI — people who have previously received the individual drugs in FOLFIRI may still be eligible, as long as any serious (Grade 3) side effects have resolved
• People with a life expectancy of at least 3 months
• People with a general health/activity level rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work)
• People with blood counts, kidney function, liver function, and heart measurements within acceptable ranges at the screening visit (confirm specific values with the trial site)
• People who have a stored tumour tissue sample (from a biopsy that has not yet been treated) available for testing
• People who are able to swallow and take oral (by mouth) medications
• Men with female partners who could become pregnant must be willing to use adequate contraception from the first dose until 180 days after the last dose of treatment
• Women who could become pregnant must have a negative pregnancy test at the start of the study
• Women who could become pregnant must be willing to use adequate contraception from the first dose until 180 days after the last dose of treatment
• People who are willing and able to follow the study requirements

Who may not be able to join:

• People whose best response to the EC treatment was that the cancer continued to grow (progressive disease)
• People who have medical reasons that prevent them from taking the targeted therapy drugs (BRAF inhibitor/anti-EGFR) used in the trial
• People who have medical reasons that prevent them from taking irinotecan or fluoropyrimidine chemotherapy drugs
• People with a known deficiency of an enzyme called DPYD (which affects how certain chemotherapy drugs are processed by the body)
• People with a life expectancy of 3 months or less
• People with a general health/activity level rated higher than 1 on the ECOG scale (meaning limited self-care ability)
• People who have experienced any of the following in the 6 months before starting treatment: heart attack, acute coronary problems (including unstable angina, bypass surgery, angioplasty, or stenting), moderate-to-severe heart failure, serious heart rhythm problems (excluding atrial fibrillation and certain controlled conditions), stroke, or a blood clot in the lungs causing symptoms
• People with a genetic heart condition called congenital long QT syndrome
• People with digestive system problems that could affect how the body absorbs one of the study drugs, such as uncontrolled vomiting, poor absorption conditions, or significant small bowel removal
• People with uncontrolled blood clotting problems
• People with a known history of Gilbert's syndrome, or who carry specific gene variants (UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28) that affect how certain drugs are processed (confirm with trial site)
• People with an active infection currently requiring treatment with systemic (whole-body) medication
• People with a known history of acute or chronic pancreatitis (inflammation of the pancreas)
• People with a known history of HIV infection or AIDS
• People with active Hepatitis B or Hepatitis C virus infection detected at the screening visit
• People with brain metastases causing symptoms, or cancer spread to the lining of the brain or spinal cord
• People who have had a serious allergic reaction or severe side effects to any of the planned study drugs in the past
• People with ongoing side effects from previous cancer treatment rated above Grade 2 (except hair loss or nerve-related symptoms)
• People currently taking certain medications that interact with the study drugs, including strong inhibitors of a liver enzyme called CYP3A4, taken within 1 week before starting the study (confirm specific medications with the trial site)
• People currently taking St. John's Wort (a herbal supplement)
• People with other serious medical or mental health conditions, or significant abnormal lab results, that the investigator believes would make participation unsafe or affect study results
• People who have had another cancer diagnosis in the past 3 years, with some exceptions for certain treated or non-invasive skin cancers and other specified low-risk cancers (confirm with trial site)
• Women who are pregnant or breastfeeding, or women of childbearing potential who have a positive or no pregnancy test at the start of the study
• People who are sexually active and unwilling to use contraception during the study and for 180 days after the last treatment dose

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