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:

• You have a cancer (other than non-small cell lung cancer) that has been confirmed to have a specific gene change called a "ROS1 fusion," found through a type of genetic testing called next-generation sequencing.
• You are willing and able to have a fresh tissue sample (biopsy) taken before treatment starts, as well as blood samples taken for research purposes (for blood cancers or certain childhood cancers, other sample types may be acceptable instead).
• Your body surface area (a measure related to your height and weight) is at least 0.43 m² (confirm with trial site).
• You are an adult (aged 18 or over) with kidneys, liver, and blood counts working well enough to meet the trial's requirements (specific levels will be checked).
• You are under 18 years old with kidneys, liver, and blood counts working well enough to meet the trial's requirements (specific levels will be checked).
• If you are a woman who could become pregnant, you have a negative pregnancy test before joining and agree to use at least one highly effective form of contraception (such as the pill, an intrauterine device, or having a partner who has had a vasectomy) plus a barrier method if using hormonal contraception, starting from your first dose and continuing for five weeks after your last dose — or you agree to complete sexual abstinence for that period.
• If you are a man whose partner could become pregnant, you agree to use a condom (plus spermicide) or to abstain from sex from your first dose until three months after your last dose, and to ensure your partner also uses effective contraception; if your partner is pregnant or breastfeeding, you must use a condom to protect them from the drug.
• All male patients must also agree not to donate sperm from their first dose until three months after their last dose.

Who may not be able to join:

• You are a woman who is pregnant, breastfeeding, or planning to become pregnant during the trial or within five weeks of your last dose.
• You have been diagnosed with ROS1 fusion-positive non-small cell lung cancer (NSCLC).
• You have previously been treated with a drug from the same family as entrectinib, unless genetic testing shows your cancer has a specific resistance pattern that entrectinib may still be able to target (confirm with trial site).
• You have serious heart problems, including severe heart failure, a recent heart attack or unstable chest pain within the last three months, significant heart valve disease, a clinically important irregular heartbeat in the last three months, or a stroke in the last three months (some exceptions may apply — confirm with trial site).
• Your heart's electrical activity (measured by an ECG) shows a reading called QTcF that is too long — over 450 milliseconds for men or 470 milliseconds for women — or you have an inherited condition affecting heart rhythm, or you take medicines known to affect heart rhythm.
• You have a personal or family history of a heart rhythm condition called Torsades de Pointes or long QT syndrome.
• You have moderate or severe nerve damage in your hands or feet (called peripheral neuropathy, grade 2 or higher).
• You have an active serious infection (bacterial, fungal, or viral); if you are HIV-positive, you may still be eligible if your immune system is strong enough, your viral load is undetectable, you have been on stable HIV treatment for at least four weeks, and you have not had any serious HIV-related infections in the past 12 months (confirm with trial site).
• You have a known allergy to entrectinib or any of its ingredients.
• You have received a live vaccine within 28 days before joining the trial, or expect to need one during treatment or within six months of your last dose.
• You are unable to swallow the capsules whole (without chewing, crushing, or opening them), or you have an active gut condition such as Crohn's disease, ulcerative colitis, or another condition that could affect how your body absorbs the medicine.
• You have a personal history of significant bone thinning (osteoporosis/osteopenia) (confirm with trial site).
• You have another serious illness or condition that the trial doctor believes would make it unsafe for you to participate or could interfere with how the trial is run.

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