Phase 2 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 16 or older, of any gender
• People who have been diagnosed with NF2-associated nerve sheath tumors, either using the revised 2022 diagnostic criteria or confirmed through laboratory tissue analysis
• People who either had surgery that did not fully remove the tumor, have had the tumor come back after surgery, or whose doctor has determined that systemic (whole-body) treatment is needed
• People who have at least one tumor that can be measured using standard imaging criteria (REiNS or RECIST v1.1)
• People with a physical functioning score of 70 or above on the Karnofsky scale, which means they are able to care for themselves and carry out normal activity with only minor difficulty (confirm with trial site)
• People whose liver, kidneys, and bone marrow are working well enough to meet the trial's requirements
• People whose blood clotting test results (INR and APTT) are within an acceptable range, no more than 1.5 times the upper limit of normal
• People who are able to become pregnant or father a child and who agree to use highly effective contraception during treatment and for at least 90 days after the last dose
• People who are willing to limit sun exposure and use adequate sunscreen when going out in the sun
• People who are able to understand the trial and sign a written consent form voluntarily

Who may not be able to join:

• People who have received certain drug or biological treatments within the past 3 weeks, or within 5 half-lives of that treatment — whichever period is longer
• People who have used medications that boost platelet, red blood cell, or white blood cell levels within the past 7 days
• People who have had major surgery or received anti-tumor immunotherapy within the past 4 weeks
• People who have had radiation therapy for nerve sheath tumors within the past 4 weeks
• People whose steroid medication dose (such as dexamethasone) was adjusted within the past week
• People who have taken part in another interventional clinical trial within the past 4 weeks
• People who have previously been treated with Selumetinib or any other MEK 1/2 inhibitor drug
• People who have a history of, or currently have, another type of cancer
• People who are unable to have an MRI scan or have a medical reason preventing them from having one
• People with high blood pressure that is not well controlled
• People who have difficulty swallowing, an active digestive system disease, a condition affecting how the body absorbs medication, or any other condition that could interfere with how the trial drug is absorbed
• People with a past or current eye condition affecting the blood vessels in the retina
• People with a lung condition called interstitial pneumonitis (inflammation of the lung tissue)
• People with certain heart conditions or related health problems (confirm specific details with trial site)
• People with a close family history of sudden cardiac death before the age of 50
• People with a history of any sudden or serious neurological condition (confirm with trial site)
• People who currently have an active bacterial, fungal, or viral infection
• People who are known to be allergic or sensitive to the trial drug, other MEK 1/2 inhibitor drugs, or any of their ingredients

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