Phase 3 Peripheral Neuropathy 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 18 or older at the time of signing the consent form
• People who have been diagnosed with neurofibromatosis type 1 (NF1) with a type of nerve tumour called a plexiform neurofibroma that cannot be removed by surgery, is causing symptoms, and in the treating doctor's judgement needs systemic (whole-body) treatment
• People who have at least one tumour measuring 3 cm or more in its largest dimension
• People whose use of long-term nerve pain medications has not changed significantly in the 28 days before joining the study
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1)
• People whose blood and other laboratory test results meet the specific standards set out in the study protocol
• Women who could become pregnant must agree to use effective contraception during the study and for 6 months after it ends, and must have a negative blood pregnancy test within 7 days before joining
• Men must agree to use effective contraception during the study and for 6 months after it ends
• People who are willing to take part voluntarily, sign the consent form, and follow the study requirements

Who may not be able to join:

• People with a confirmed or suspected high-grade brain tumour (malignant glioma) or a cancerous nerve sheath tumour (MPNST), though certain low-grade or non-treated eye nerve tumours may be exceptions (confirm with trial site)
• People who have had another cancer in the 5 years before the first dose, or who currently have another cancer
• People who have conditions that make it hard to swallow or absorb oral medication, such as chronic diarrhoea, a bowel blockage, or previous major bowel surgery
• People who still have significant side effects from previous cancer treatment that have not recovered to a mild level, with some specific exceptions such as certain levels of hair loss, nerve pain, anaemia, or thyroid issues managed with medication (confirm with trial site)
• People who have had major surgery or a serious injury in the 4 weeks before the first dose, who have planned major surgery during the study, or who have wounds or fractures that have not healed
• People who have had a blood clot in an artery or vein — such as a stroke, mini-stroke (TIA), deep vein thrombosis, or pulmonary embolism — within the 6 months before the first dose
• People with active viral hepatitis that is not well controlled
• People with active syphilis that requires treatment
• People with active tuberculosis, certain lung conditions such as pulmonary fibrosis or drug-related lung inflammation, or active pneumonia with symptoms
• People with a history of substance abuse that cannot be managed, or who have a psychiatric disorder
• People who have had, or are planned to have, a bone marrow or organ transplant from another person
• People with a history of a condition where the liver affects brain function (hepatic encephalopathy)
• People with a history of or current eye conditions including retinal vein blockage, retinal detachment, central serous retinopathy, glaucoma, or other significant eye problems including raised eye pressure above 21 mmHg
• People who are unable to have an MRI scan or who have a medical reason they cannot undergo MRI
• People with serious heart or cardiovascular disease
• People with an active or uncontrolled severe infection
• People with kidney failure requiring dialysis
• People with a history of immune system deficiency, including HIV, or other conditions that weaken the immune system
• People with a history of epilepsy
• People currently receiving treatment for tumour-related symptoms (confirm with trial site)
• People with a known allergy or sensitivity to any ingredient in the study medication
• People who have taken part in another clinical trial for plexiform neurofibroma or used another trial drug within the 4 weeks before the first dose
• People who are pregnant or breastfeeding
• People whom the treating doctor considers to be at serious risk or who have any other condition that may interfere with completing the study

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