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 been diagnosed with a cancer that tests positive for an ALK gene change, confirmed using an approved genetic testing method.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and agree to use a highly effective form of contraception (such as the pill, implant, IUD, or abstinence) from the start of treatment until 3 months after your last dose.
• If you are a man whose partner could become pregnant, you must agree to use barrier contraception (condom plus spermicide) or abstinence, and your partner must also use a highly effective contraceptive method, from the start of treatment until 3 months after your last dose; you must also not donate sperm during this time.
• You must be willing and able to have a fresh tissue sample (biopsy) taken; for some blood cancers or neuroblastoma, a blood, bone marrow, or lymph node sample may be taken instead.
• If you are under 18 years old, you must weigh at least 40 kg (about 88 lbs).
• You must have kidneys, liver, and blood counts that are working well enough, as confirmed by blood tests outlined in the trial rules.

Who may not be able to join:

• You have been diagnosed with ALK-positive non-small cell lung cancer (this is a different trial).
• You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 3 months of your last dose.
• You have previously been treated with a drug in the same class as alectinib, unless your genetic test shows your cancer has a specific change that might still respond to alectinib; however, prior treatment with a drug called crizotinib (Xalkori®) is allowed.
• You have a history of, or scan evidence showing, a lung condition called interstitial lung disease or pneumonitis (lung inflammation), unless it was caused by localised radiotherapy, has fully resolved, you are off steroids, and you have had no symptoms for more than 6 months.
• You are at risk of a tear or hole in your gut (for example, if you have a history of diverticulitis or take certain medications that raise this risk, unless you are also on stomach-protecting medication).
• You are unable to swallow tablets or have a gut condition that affects how oral medicines are absorbed (such as after major bowel surgery); children who cannot swallow the capsules are also excluded.
• You have a serious pre-existing heart condition, such as uncontrolled chest pain (angina), uncontrolled irregular heartbeat in the past 3 months, or severe heart failure; or you have had a stroke, mini-stroke (TIA), or heart attack in the 3 months before starting the trial (confirm with trial site regarding brain tumour-related exceptions).
• You have previously had an organ transplant.
• You have a heart rate that is already abnormally slow in a way that is causing symptoms.
• You have a known allergy to alectinib or any of its ingredients.
• You have received a live vaccine (such as MMR or yellow fever) within 28 days before joining, or expect to need one during treatment or within 6 months after your last dose.
• You have active hepatitis B or C, or are HIV-positive, unless your HIV is very well controlled with medication, your immune system is in good shape, and you have had no HIV-related infections in the last 12 months (confirm with trial site).
• You or a close family member have a history of bone disorders, or you are known to have low bone density (osteopenia).
• You have another significant illness or condition that the trial doctor believes would make it unsafe for you to take part, or that could interfere with how the trial medicine works.

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