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:

• People aged at least 6 months, with the upper age limit depending on the group being enrolled (some groups are open to people under 21, one group is for people aged 21 and older — confirm which group applies with the trial site).
• People who are able to take medication by mouth, or through a feeding tube such as a nasogastric or gastric tube (the study medication comes as a liquid suspension or tablet only).
• People who have a confirmed diagnosis of LCH (Langerhans cell histiocytosis), proven by a tissue biopsy, AND who have already tried at least one standard treatment that did not work, with measurable disease still present.
• People who have LCH-related nerve or brain disease (called LCH neurodegenerative disease) that has shown signs of getting worse — either on imaging or based on symptoms — within the past 3 months.
• People with a confirmed biopsy diagnosis of JXG, ECD, RDD, histiocytic sarcoma, or another histiocytic condition (either newly diagnosed or returning after previous treatment), with measurable active disease.
• People whose general physical ability to carry out daily activities meets a minimum level — scored at 50% or above on standard medical scales used for their age group.
• People whose blood counts meet minimum levels: white blood cell count, platelet count, and haemoglobin levels must all be at or above specified thresholds (the trial site will check these with blood tests).
• People whose kidneys are functioning at or above a minimum level, based on blood or urine tests (the trial site will assess this).
• People whose liver is functioning adequately, based on blood test results — those with liver disease caused by a histiocytic condition may still be considered even if some liver values are abnormal (confirm with trial site).
• People whose heart is functioning adequately, confirmed by an echocardiogram (heart ultrasound) done within 28 days before joining.
• Female participants of childbearing potential who have a negative pregnancy test before joining, and who agree to use two effective forms of contraception throughout the study.
• Male participants whose partners could become pregnant, who agree to use two effective forms of contraception (including at least one barrier method) during treatment and for at least 3 months after the last dose; committed abstinence (not periodic or withdrawal methods) is also accepted.

Who may not be able to join:

• People currently taking certain medications that strongly affect how the body processes drugs — specifically strong CYP3A4 inducers or inhibitors (such as erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, St. John's wort, or grapefruit juice) within 14 days before joining.
• People who have not yet completed previous chemotherapy, immunotherapy, radiation, or targeted therapy for at least 28 days before joining, or who still have significant side effects from prior treatment (with exceptions for hair loss and hearing-related side effects).
• People who have had radiation therapy within 14 days before joining.
• People who have previously been treated with Cobimetinib (the study drug).
• People who have received long-acting blood cell growth factor treatment within 14 days, or short-acting growth factor treatment within 7 days, before joining.
• People who have had hormonal therapy (other than hormone replacement or contraceptives), immunotherapy, biological therapy, experimental therapy, or herbal cancer therapy within 28 days (or within 5 half-lives of the drug, whichever is longer) before joining.
• People who have had a high-dose chemotherapy treatment with stem cell rescue, or a stem cell/bone marrow transplant, within 90 days before joining; or who are still taking anti-rejection medications (such as cyclosporine or tacrolimus) after a transplant.
• People with brain tumours who have taken blood-thinning (anticoagulant) medication within 7 days before joining.
• People taking blood-thinning medication or who have a pre-existing bleeding disorder unrelated to their histiocytic disease.
• People who have received corticosteroids at more than 0.5 mg/kg/day on average in the 28 days before joining, or whose corticosteroid dose has not been stable or decreasing for at least 14 days before joining.
• People who have received any other experimental (investigational) treatment within 4 weeks before joining.
• People with another active cancer, or a history of a second cancer.
• People with severe ongoing nausea and vomiting, significant problems absorbing food or medication, or an external bile drainage tube.
• People who have an active infection (other than a fungal nail infection) that has not completely resolved within 28 days before joining.
• People who have had a major surgery or serious injury within 28 days before joining, or who are expected to need major surgery during the study period (minor procedures such as placement of a vascular access device are generally permitted if the wound has healed).
• People with a history of significant bowel removal or other conditions that seriously affect the body's ability to absorb medication.
• People with a history of lung inflammation (pneumonitis).
• People with certain eye conditions or known risk factors for eye problems — including a history of retinal vein blockage, retinal detachment, certain retinal diseases, raised pressure in the eye, uncontrolled high blood pressure, diabetes, or high cholesterol; people with longstanding and stable eye conditions related to an existing diagnosis may be considered with written approval from the study chair (confirm with trial site).
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People with any other serious medical, physical, or psychological condition that the treating doctor believes would make participation unsafe.
• People with a history of clinically significant heart problems, including serious heart rhythm disorders (unless it is controlled atrial fibrillation), unstable heart rhythms, unstable chest pain or new chest pain within 3 months, heart failure classified as moderate or severe, or a heart attack within 3 months before joining.
• People with a known chronic HIV infection.
• People with a history of moderate or severe bleeding in the brain, or any brain bleeding within 28 days before joining.
• People who are pregnant or currently breastfeeding.

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