Phase 2 Study of Abemaciclib Versus Placebo in Adults with Newly Diagnosed Grade 3 Meningioma Showing RB Protein

What this Trial Is About

Researchers are evaluating how the investigational drug abemaciclib works in treating patients with newly diagnosed grade 3 meningioma, a type of brain tumor. Abemaciclib is an FDA-approved drug but not yet approved for brain tumors. This phase 2 randomized clinical trial compares abemaciclib with a placebo to study their effects in treating brain tumors, with neither participants nor researchers knowing which treatment is given to maintain objectivity. Participants who consent will have surgical tissue collected during planned surgery to test for RB-positive cells. Qualified participants will be randomly assigned to receive either abemaciclib or placebo, both given as tablets twice daily for 28 days per cycle. Treatment begins two to five weeks after completing standard-of-care radiation therapy. The study uses a double-blind design, meaning neither participants nor study staff know which treatment is given. During the trial, participants will attend scheduled visits and undergo laboratory tests to monitor their health and treatment effects. Researchers will measure progression-free survival over 24 months as the main outcome, along with monitoring drug-related toxicities, adverse events, deaths, and overall survival for up to 60 months. Participants will be followed closely for safety and treatment response throughout the study period, which starts from randomization.

Abemaciclib in Newly Diagnosed Meningioma Patients