NCT05940493 Abemaciclib in Newly Diagnosed Meningioma Patients
| NCT ID | NCT05940493 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nader Sanai |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2028-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 proce