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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Tablet
Tablet
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
RECRUITINGProgression-Free Survival Characteristics Over 24 Months
Progression-free survival at 24 months (PFS24) will be analyzed using Kaplan-Meier methods.
Time frame: Date of randomization to date of protocol-defined disease progression, assessed up to 24 months
Incidence of Drug-related Toxicities
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame: Date of first dose up to 30 days after last dose
Incidence of Adverse Events as Assessed by CTCAE v5.0
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame: Date of randomization up to 30 days after last dose
Incidence of Deaths
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame: Date of first dose to date of death due to any cause, assessed over 60 months
Incidence of Clinical Laboratory Abnormalities as Assessed by CTCAE v5.0
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame: Date of randomization up to 30 days after last dose
Progression-Free Survival Characteristics Over 12 Months
Progression-free survival at 12 months (PFS12) will be analyzed using Kaplan-Meier methods.
Time frame: Date of randomization to date of protocol-defined disease progression, assessed up to 12 months
Overall Survival Characteristics Over 24 Months
Overall survival at 24 months (OS24) will be analyzed using Kaplan-Meier methods.
Time frame: Date of randomization to date of death due to any cause, assessed up to 24 months
Median Overall Survival
Time frame: Date of randomization to date of death due to any cause, assessed up to 60 months
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