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 who have been diagnosed with Neurofibromatosis Type 1 (NF1) — this means having at least two of the recognised signs of NF1 (such as café-au-lait spots, freckles in the armpit or groin, neurofibromas, an eye tumour called optic glioma, Lisch nodules in the eyes, certain bone abnormalities, or a close family member with NF1), or having a confirmed NF1 gene mutation from an approved laboratory
• People who have at least one measurable atypical neurofibroma (ANF) — a specific type of tumour that is at least 3 cm in size and can be assessed using a specialised MRI scan (the trial site must confirm this before enrolment)
• People who have not previously received chemotherapy for their ANF may still be considered, as there is no standard effective chemotherapy for this condition
• People who have previously received investigational or biological therapies may be considered, provided at least 30 days or 5 half-lives have passed since that treatment, and side effects have largely resolved
• People who have previously received chemotherapy may be considered, provided side effects have largely resolved and at least 28 days have passed since the last dose
• People who have previously received radiation therapy may be considered, provided at least 6 weeks have passed since the last treatment and the target ANF tumour has not itself been previously irradiated
• People who have had major surgery may be considered, provided at least 28 days have passed and the wound has healed well
• People who are able to carry out daily activities at a reasonable level, as measured by a standard performance scale (Lansky/Karnofsky score of 70% or above)
• People whose blood counts, liver function, kidney function, and heart function meet the specific healthy ranges required by the trial
• People who are willing to avoid grapefruit and grapefruit juice during treatment
• People (or their legal guardian if under 18) who are willing and able to sign an informed consent form
• Women who are able to become pregnant must have a negative pregnancy test within 7 days of starting treatment, and both male and female participants must agree to use highly effective contraception during treatment and for at least 4 months after the last dose
• For the Phase 0 part of the trial only: Adults aged 18 or older who have at least one measurable ANF confirmed by biopsy, where surgical removal is clinically appropriate and would not be expected to cause significant harm
• For the Phase I/II part of the trial only: People aged 12 or older with a body surface area of at least 0.71 m² who are able to swallow whole tablets, and who have at least one biopsy-confirmed ANF where surgery would likely cause significant harm, or where the person is unwilling to have surgery, or where there is more than one distinct nodular lesion including at least one biopsy-confirmed ANF
• People aged 12–17 in the Phase I/II part must be willing to undergo a pre-treatment biopsy of the ANF if it can be done safely; people aged 18 and over must be willing to undergo both a pre-treatment and an on-treatment biopsy if it can be done safely (this requirement may be waived if a safe biopsy is not possible, confirm with trial site)

Who may not be able to join:

• Women who are pregnant, planning to become pregnant during the study, or who are breastfeeding
• People who have another NF1-related tumour — such as an optic pathway glioma or a malignant peripheral nerve sheath tumour — that currently requires chemotherapy or surgery
• People with serious pre-existing medical conditions that could interfere with participation, such as interstitial lung disease, severe breathlessness at rest requiring oxygen, a history of major stomach or small bowel surgery that could affect how medication is absorbed, or pre-existing Crohn's disease, ulcerative colitis, or another ongoing condition causing persistent moderate-to-severe diarrhoea
• People with uncontrolled ongoing illness, including uncontrolled heart failure, unstable chest pain (angina), irregular heartbeat, active bleeding disorders, a history of kidney transplant, or mental health or social circumstances that would make it difficult to follow the study requirements
• People with a personal history of fainting due to a heart problem, dangerous heart rhythm problems (such as ventricular tachycardia or fibrillation), or sudden cardiac arrest
• People with an active bacterial infection currently requiring intravenous antibiotics, an active fungal infection, or a detectable viral infection such as active hepatitis B or C (note: people living with HIV who have adequate immune function and do not need antiviral treatment may still be considered — confirm with trial site)
• People with interstitial lung disease (a type of chronic lung condition)
• People who need to take strong medications that significantly interact with an enzyme called CYP3A, which affects how the study drug is processed by the body (confirm with trial site)
• People who are unable to swallow tablets whole, as the tablets cannot be crushed or broken
• People who are unable to have an MRI scan, or who have implants, prostheses, or dental or orthopaedic braces that would interfere with the MRI analysis of the target tumour
• People with persistent nausea and vomiting that, in the doctor's opinion, would prevent them from taking the study medication reliably
• People with a known severe allergy to abemaciclib (the study drug) or any of its ingredients, or a history of allergic reactions to chemically similar compounds
• People who have previously been treated with abemaciclib or another CDK4/6 inhibitor
• People whom the investigating doctor considers should not participate in the study for clinical reasons

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