At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed intracranial WHO Grade 3 meningioma or histopathologically confirmed transformation from lower grade to Grade 3
- ✓Plan to receive or have received upfront standard of care radiation therapy for Grade 3 meningioma
- ✓No prior treatment for Grade 3 meningioma except surgical resection/biopsy and upfront RT; if previously lower grade, no prior treatment except surgical resection/biopsy and no prior RT
- ✓Age ≥18 years at time of consent
- ✕Prior history of cancer with ongoing treatment of disease
- ✕Pregnancy or breastfeeding
- ✕Known allergic reactions to components of abemaciclib
- ✕Active infection or fever >38.5°C requiring systemic therapy within 4 weeks of Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants
In Brief
A Phase 2 clinical trial evaluating Abemaciclib and Placebo for Meningioma. Currently recruiting, targeting 72 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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