Phase 2 Interstitial Lung 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:

• Children and adolescents between the ages of 2 and 16 (inclusive)
• People with a confirmed diagnosis of Langerhans cell histiocytosis (LCH), a rare disease where abnormal cells build up in the body, confirmed by a central laboratory
• People whose tumor tissue and blood samples are available for genetic testing at a central laboratory, or whose local laboratory genetic test results can be accepted if tissue samples cannot be obtained
• People who have already received at least one round of standard treatment (including the chemotherapy drugs vinblastine, vincristine, or vindesine, combined with steroids, for at least 2 weeks), or people who were unable to tolerate chemotherapy due to serious side effects such as severe liver damage, severe nerve-related side effects, pressure buildup in the brain, or serious bone marrow problems with infection
• People whose LCH has either not responded to treatment, has come back after treatment, has shown persistent signs of disease activity in blood tests during or after treatment, has not improved in the brain or pituitary gland with treatment, or involves the bone marrow or a related condition called hemophagocytic lymphohistiocytosis (HLH)
• People who have at least one area of disease that can be measured and tracked using a specialised type of scan (PET scan)
• People who have recovered from the serious side effects of any previous cancer treatments, with any remaining side effects being mild (grade 1 or lower), except for hair loss or hearing changes
• People with an expected survival of at least 3 months
• People with a performance status score of 50% or higher on age-appropriate scales, meaning they are able to manage some level of daily activity (confirm with trial site)
• People (or their legal guardians) who are able to understand and sign a written consent form
• Women or girls who could potentially become pregnant must have a negative pregnancy blood test within 7 days before starting the study drug
• Women or girls who could potentially become pregnant must agree to use effective contraception (such as condoms, oral or injectable contraceptives, or an intrauterine device) during treatment and for at least 90 days after the last dose; male participants must agree not to donate sperm for at least 90 days after the last dose
• People with adequate bone marrow function, meaning blood counts are within acceptable ranges without the need for recent transfusions or blood-stimulating medications (those with low counts caused by the disease itself may still be considered — confirm with trial site)
• People with adequate liver and kidney function within acceptable ranges (those with liver or kidney problems caused by the disease itself may still be considered — confirm with trial site)
• People with blood clotting test results within an acceptable range

Who may not be able to join:

• People who have received chemotherapy, targeted therapy, immunotherapy, biological therapy, or herbal cancer treatments within 4 weeks (or less than 5 half-lives, whichever is shorter) before starting the study drug
• People who have taken certain strong medications that affect how the body processes drugs (specific CYP3A4, CYP2C8, or CYP2C9 inhibitors or inducers) within 14 days before starting the study drug, unless applied to the skin only
• People who have received medications that boost platelet or white blood cell levels within 7 days before starting the study drug
• People who have had radiation therapy or major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before starting the study drug
• People who have participated in another interventional clinical trial within 4 weeks before starting the study drug
• People who have previously received MEK 1/2 inhibitor drugs (though those who took them for 2 weeks or less may still be considered — confirm with trial site)
• People with brain tumours who have taken blood-thinning medications within 7 days before starting the study drug
• People who have taken steroid medications (such as prednisone) at certain doses within one month before enrolling, unless the dose has been stopped at least 14 days before starting the study drug (exceptions apply for certain situations — confirm with trial site)
• People with a history of another cancer, or a current second cancer, other than certain previously cured skin or breast cancers or cervical carcinoma in situ
• People with high blood pressure that is not controlled by medication, where blood pressure is at or above the 95th percentile for their age, height, and sex
• People who have difficulty swallowing, active digestive system disease, problems absorbing food or medications, or other conditions that may prevent the study drug from being properly absorbed
• People with a history of or current eye conditions such as blockage of a vein in the retina, detachment of the retinal pigment layer, glaucoma, or other significant eye abnormalities
• People with interstitial lung disease (scarring or inflammation of the lungs), including significant radiation-related lung inflammation, unless caused by LCH itself
• People with certain heart conditions, including a prolonged QTcF interval on a heart tracing (ECG) of more than 470 milliseconds, certain heart rhythm problems, moderate to severe heart failure, known significant coronary artery disease, cardiomyopathy, severe valve disease, or a heart pumping function (LVEF) below 50%
• People with active bacterial, fungal, or viral infections, including active hepatitis B, hepatitis C, or HIV
• People with a known allergy to the study drug, other MEK1/2 inhibitor drugs, or any of their ingredients
• People whose genetic test results show a specific type of gene change (MAP2K1 exon 3 deletion or deletion-insertion mutation) that may affect how the drug works
• People who, in the opinion of the treating doctor, have other significant medical conditions that would make participation unsafe or not possible

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