Phase 1 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 who are at least 18 years old at the time of signing the consent form.
• People who are able to understand the study, agree to take part, and sign a written consent form after being told about the study's goals, methods, possible benefits, and risks.
• People who are able to swallow tablets or capsules.
• People who have a general health level rated at 70% or above on a standard medical scale (meaning they are able to care for themselves and carry out most daily activities). Note: people who use a wheelchair due to paralysis caused by a nerve tumour, or who need breathing support devices, may still meet this requirement (confirm with trial site).
• People who have been formally diagnosed with Neurofibromatosis Type 1 (NF1) — a genetic condition that can cause tumours to grow on nerves — confirmed by at least two recognised signs or by genetic testing.
• People who have at least one symptomatic plexiform neurofibroma (a type of nerve tumour associated with NF1) that is at least 3 cm across, is causing symptoms such as pain, disfigurement, or nerve problems, and cannot be fully removed by surgery without causing serious harm — or has been partially removed with at least 15% of the tumour remaining, or has come back after a previous surgery.
• People who have at least seven small skin tumours (called cutaneous neurofibromas) that are between 6 and 15 mm in size, are not on a stalk, are not touching other skin tumours, and are visible on the surface of the skin, located on the trunk, neck, or limbs (people with fewer than seven may still be considered — confirm with trial site).
• People who are willing and able to have regular MRI scans throughout the study. Medication to help manage anxiety, claustrophobia, or pain during scans may be allowed, as determined by the study doctor.
• People who are willing and able to have regular photographs taken and measurements recorded of their skin tumours.
• People whose blood clotting levels are within an acceptable range, as confirmed by blood tests.
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning within acceptable ranges as required by the study.
• People who agree to either avoid heterosexual intercourse or use a highly effective form of contraception during the study and for at least 90 days after the last dose of the study drug. People who produce sperm must also agree not to donate sperm during treatment and for at least 90 days after their last dose.

Who may not be able to join:

• People who have taken part in another interventional clinical trial within the past 28 days.
• People who have received chemotherapy for any reason within the past 90 days.
• People who are still experiencing side effects from previous chemotherapy that are worse than mild (hair loss is an exception).
• People who have received any drug or biological treatment specifically targeting nerve tumours within the past 14 days.
• People who have recently taken certain medications known to affect the way the body processes drugs (specific enzyme pathways called CYP3A4, CYP2C8, and CYP2C9), within 14 days before starting the study drug (confirm with trial site for specific medications).
• People who have received medications to boost platelet or white blood cell counts within the past 7 days.
• People who have had radiotherapy, major surgery, or immunotherapy within the past 28 days.
• People who have a cancerous tumour related to NF1 (such as certain brain tumours or malignant nerve sheath tumours) that currently requires chemotherapy, radiotherapy, or surgery.
• People who currently have, or have been treated for, a cancer (other than certain fully treated skin cancers or early-stage breast or cervical cancers) within the past 5 years.
• People who have high blood pressure that cannot be controlled even with medication, defined as readings consistently above 150/90 mmHg. People with blood pressure that is well managed with medication may still be considered.
• People who have difficulty swallowing, significant digestive problems, or a condition affecting how their body absorbs medication.
• People who have had or currently have certain eye conditions, including blockage of a vein in the retina, detachment of a layer of the retina, active glaucoma, or other significant eye abnormalities found during screening.
• People who have a lung condition such as interstitial pneumonia or NF1-related lung disease, including significant inflammation of the lungs caused by previous radiation treatment.
• People who have significant heart problems, including a specific abnormality in heart rhythm on an ECG, moderate to severe heart failure, certain types of irregular heartbeat, significant coronary artery disease, heart muscle disease, severe valve disease, or reduced heart pumping function (below 45%) on a heart scan.
• People who have taken a medication known to affect heart rhythm (QTc-prolonging) within 7 days before starting the study drug, or longer if the medication stays in the body for more than 7 days.
• People who have an active, uncontrolled bacterial, fungal, or viral infection, including active hepatitis B, hepatitis C, or HIV with a detectable viral level.
• People who have a significant active liver disease or known liver or bile duct abnormality (except for a harmless genetic condition called Gilbert's syndrome or symptom-free gallstones).
• People who have a known allergy or sensitivity to the study drug (PAS-004), any of its ingredients, or a related type of drug called a MEK 1/2 inhibitor.
• People who are pregnant or currently breastfeeding.
• People who have any other significant health condition that the study doctor believes would make participation unsafe or difficult.
• People who are unable to attend in-person visits at the clinical trial site as required.

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