OncoMatch/Clinical Trials/NCT04750928
Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas
Is NCT04750928 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Abemaciclib for neurofibromatosis 1.
Treatment: Abemaciclib — Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery. Researchers want to see if a drug called abemaciclib can help. Objective: To find a safe, tolerable dose of abemaciclib for treating atypical neurofibromas. Eligibility: People ages 12 and older who have NF1 and have one or more atypical neurofibromas that cannot or will not be removed with surgery Design: Participants will be screened with: Medical history and physical exam Blood, urine, and heart tests MRI: Participants will lie in a machine that takes pictures of the body. A padding or coil will be placed around their head. They may have a contrast agent injected into a vein. Biopsy sample: A small piece of tumor will be removed using a large needle. Participants will have frequent visits during the study. These will include repeats of the screening tests as well as the following: PET scan: Participants will lie in a machine that takes pictures of the body. They will have a contrast agent injected into their arm. Questionnaires about the effects of abemaciclib on pain and quality of life Possible photographs of tumors Participants will take abemaciclib capsules orally twice daily in 28-day cycles. They will take the drug for up to 2 years. Some may be able to take it for longer. Participants will have a follow-up visit about 30 days after their last dose of the study drug. Then they will have visits every 3 months for 1 year. ...
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Allowed: NF1 any mutation
confirmed NF1 mutation from a CLIA-certified laboratory
Prior therapy
Cannot have received: cdk4/6 inhibitor (abemaciclib)
Lab requirements
Blood counts
absolute neutrophil count >=1500/microliter, hemoglobin >=9 g/dL (transfusion independent), platelets >=100,000/microliter (transfusion independent)
Kidney function
creatinine clearance or radioisotope GFR >=60ml/min/1.73 m2 or a normal serum creatinine based on age
Liver function
bilirubin within 1.5 x the upper limit of normal for age (except Gilbert syndrome); AST/ALT <= 3 x upper limit of normal
Cardiac function
Normal ejection fraction (ECHO or cardiac MRI) >= 53% (or institutional normal); QTC or QTcF <= 450 msec
Adequate organ function as defined below: Hematologic Function: ... Hepatic Function: ... Renal Function: ... Cardiac Function: ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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