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Abemaciclib in Newly Diagnosed Meningioma Patients

NCT05940493 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Meningioma

Interventions

DRUG

Abemaciclib

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Barrow Neurological Institute

    collaborator OTHER

  • Ivy Brain Tumor Center

    collaborator OTHER

  • Nader Sanai

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · Ivy Brain Tumor Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2028-09-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05940493 on ClinicalTrials.gov