OncoMatch/Clinical Trials/NCT05940493
Abemaciclib in Newly Diagnosed Meningioma Patients
Is NCT05940493 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Abemaciclib for meningioma.
Treatment: Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage GRADE 3 (WHO)
Grade: 3 (WHO)
newly diagnosed intracranial WHO Grade 3 meningioma; or...histopathologically confirmed newly transformation to Grade 3
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — upfront for newly diagnosed WHO Grade 3 meningioma
Plan to receive or have received upfront standard of care radiation therapy (RT) for the newly diagnosed WHO Grade 3 meningioma
Cannot have received: any therapy for Grade 3 meningioma other than surgical resection or biopsy and upfront RT
No prior treatment for Grade 3 meningioma other than surgical resection or biopsy and upfront RT
Cannot have received: any therapy for lower grade meningioma other than surgical resection or biopsy; no prior RT
If previously diagnosed with a lower grade meningioma, no prior treatment other than surgical resection or biopsy and no prior RT
Cannot have received: CDK4/6 inhibitor
Prior therapy with any CDK4/6 inhibitor. Prior therapy is defined as therapeutic dosing.
Lab requirements
Blood counts
absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, and hemoglobin ≥8.0 g/dL (individual may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after any erythrocyte transfusion)
Liver function
total bilirubin ≤1.5x ULN (individuals with Gilbert's syndrome with a total bilirubin ≤2.0x ULN and direct bilirubin within normal limits are permitted), AST/SGOT ≤3x ULN, and ALT/SGPT ≤3x ULN
adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): Adequate Bone Marrow Function: absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, and hemoglobin ≥8.0 g/dL...Adequate Hepatic Function: total bilirubin ≤1.5x ULN (individuals with Gilbert's syndrome with a total bilirubin ≤2.0x ULN and direct bilirubin within normal limits are permitted), AST/SGOT ≤3x ULN, and ALT/SGPT ≤3x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
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