Clinical Trial

Abemaciclib in Newly Diagnosed Meningioma Patients

Recruiting Phase 2
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Summary
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma. Abemaciclib is a drug that is approved by the FDA, but not for brain tumors. Participants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested. If the tissue shows positive results for RB cells and participants are qualified, they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy. This is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance, like a flip of a coin. Neither the participant nor the researcher chooses the assigned group. Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors. This is a double-blinded study, which means that neither the participant nor the study team will know which treatment the participant is receiving.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-07-04; most recent amendment 2026-03-11.
Status change: Not Yet Recruiting → Recruiting 2025-02-25
Trial Details
NCT Number NCT05940493
Lead Sponsor Nader Sanai
Collaborators: Eli Lilly and Company, Barrow Neurological Institute, Ivy Brain Tumor Center
Conditions Meningioma
Enrollment 72 participants
Start Date 2025-03-24
Primary Completion 2028-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-13