Phase 3 Rare Disease 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 been confirmed to have a MET-positive cancer, identified through a type of advanced genetic testing (called next-generation sequencing) that detects specific MET changes in the cancer.
• People who are 18 years of age or older.
• Women who could become pregnant may be considered, provided they have a negative pregnancy test before joining and agree to use a highly effective form of contraception (one with a failure rate below 1%) starting from the first dose, throughout the trial, and for seven days after the last dose — accepted methods include hormonal contraception, an intrauterine device (IUD or IUS), tubal occlusion, a vasectomised partner, or complete sexual abstinence.
• Male participants whose partners could become pregnant may be considered, provided they agree to use a barrier method (such as a condom) or abstain from sex during the same period, and ensure their partner also uses a highly effective contraceptive method; those with pregnant or breastfeeding partners must use a barrier method to protect the unborn baby or infant from exposure to the drug.
• All male participants must also agree not to donate sperm from the first dose until seven days after the last dose.
• People who are willing and able to have a fresh tissue biopsy taken at the start of the trial, as well as blood samples taken for research purposes (for blood cancers or neuroblastoma, bone marrow or lymph node samples may be taken instead).
• People whose liver, kidney, and blood counts are within acceptable ranges as defined by the trial protocol (confirm with trial site).

Who may not be able to join:

• People who have been diagnosed with a specific type of lung cancer (non-small cell lung cancer, or NSCLC) with particular MET gene changes (METex14 skipping mutation or MET amplification).
• People who have previously been treated with a targeted MET-blocking therapy or a therapy targeting HGF, unless their cancer's genetic profile shows a specific type of resistance that capmatinib may still be able to overcome.
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord (a condition called carcinomatous meningitis).
• People who have been diagnosed with, or received treatment for, another cancer in the past three years — with exceptions for certain completely removed skin cancers (basal cell or squamous cell) or completely removed early-stage (in situ) cancers of any type.
• People who have a history of, or currently have, a lung condition involving scarring or inflammation of lung tissue (interstitial lung disease or interstitial pneumonitis), including significant radiation-related lung inflammation, or who show signs of active lung inflammation on a recent chest scan — though past radiation-related pneumonitis may be acceptable if it has fully resolved, the person has been off steroids, and has had no symptoms for at least six months.
• People with significant or uncontrolled heart problems, including unstable chest pain (angina) within the past three months, a heart attack within the past three months, a history of moderate-to-severe heart failure, or blood pressure that remains too high (systolic 160 mmHg or above and/or diastolic 100 mmHg or above) despite medication.
• People who have had a stroke or mini-stroke (transient ischaemic attack) within three months before the screening visit.
• People with certain serious heart rhythm problems detected on an ECG (heart tracing), a personal or family history of a specific inherited heart rhythm disorder (long QT syndrome or Torsades de Pointes), or a heart measurement on the ECG that is above the safe threshold for the trial.
• People who have had major surgery (such as chest, abdominal, or pelvic surgery) within four weeks before starting treatment, or who have not yet recovered from a recent major surgery — a shorter two-week waiting period applies for brain surgery; minor procedures such as VATS or mediastinoscopy require only one week.
• People who are taking certain strong medications that interfere with how the body processes capmatinib (specifically, strong CYP3A inducers), unless those medications can be stopped at least one week before starting the trial drug.
• People with any other significant medical condition or treatment that the trial doctor believes would make participation unsafe or would interfere with the trial.
• People with significant problems affecting the digestive system that could prevent the body from absorbing the trial drug properly (such as Crohn's disease, severe nausea, vomiting, diarrhoea, or conditions affecting nutrient absorption) — or people who are unable to swallow the tablets whole without chewing or crushing them.
• People with active infections, including active hepatitis B, hepatitis C, or HIV — though people with a well-controlled chronic hepatitis B or C infection on antiviral therapy, or people living with HIV who meet specific health requirements (including a sufficient immune cell count, undetectable virus levels, stable antiviral therapy that does not interact with the trial drug, and no serious HIV-related infections in the past 12 months) may be considered (confirm with trial site).
• People who are known to be allergic to any ingredient in the capmatinib tablet.
• People whose cancer has spread to the brain or nervous system and who are experiencing worsening neurological symptoms, or who have needed increasing doses of steroids in the two weeks before joining to control those symptoms — though people with primary brain tumours or brain metastases who are clinically stable may be considered, providing their steroid dose has been stable or decreasing for at least 14 days before starting treatment.
• People who are taking certain anti-seizure medications that affect how the body processes drugs, unless those medications can be stopped at least one week before the first dose.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial or within seven days of their last dose.
• People who have received a live or weakened (attenuated) vaccine within 28 days before joining the trial, or who expect to need one during treatment or within six months of their last dose.

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