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Abemaciclib in Newly Diagnosed Meningioma Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Abemaciclib in Newly Diagnosed Meningioma Patients

A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants

NCT05940493•Nader Sanai

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with newly diagnosed intracranial WHO Grade 3 meningioma; or,
•Participants with previous lower grade meningioma and histopathologically confirmed newly transformation to Grade 3.
•Plan to receive or have received upfront standard of care radiation therapy (RT) for the newly diagnosed WHO Grade 3 meningioma.
•No prior treatment for Grade 3 meningioma other than surgical resection or biopsy and upfront RT. If previously diagnosed with a lower grade meningioma, no prior treatment other than surgical resection or biopsy and no prior RT.
•Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
•Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative\[s\], and assent, if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally document and witnessed, ideally via an independent trusted witness. Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
•Age ≥18 years at time of consent.
•Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
•Ability to swallow oral medications.
•Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):
+5 more criteria

Exclusion Criteria

•Prior history of cancer with ongoing treatment of disease.
•Pregnancy or breastfeeding.
•Known allergic reactions to components of the abemaciclib.
•Active infection or fever \>38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.
•Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis.
•Known active systemic bacterial infection (requiring IV antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known HIV positivity or with known HBV or HCV). Screening is not required for enrollment.
•Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
•Prior therapy with any CDK4/6 inhibitor. Prior therapy is defined as therapeutic dosing.
•Treatment with another investigational drug within 5 half-lives of the investigational product.

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Key Dates

Start Date

March 24, 2025

Primary Completion Date

September 1, 2028

Completion Date

September 1, 2030

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Meningioma

Interventions

Abemaciclib

DRUG

Placebo

DRUG

Contacts

Ivy Research Navigator

CONTACT

602-406-8605 research@ivybraintumorcenter.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Abemaciclib in Newly Diagnosed Meningioma Patients

Inclusion Criteria

Exclusion Criteria

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