Abemaciclib in Newly Diagnosed Meningioma Patients
ABOUT THE MENINGIOMA CLINICAL TRIAL
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a randomized Phase 2 study to evaluate a drug called abemaciclib in patients with newly diagnosed grade 3 meningioma, including meningioma that was previously lower grade and has undergone malignant transformation.
Abemaciclib is a drug that is approved by the FDA but not for brain tumors. It is a highly specific CDK4/6 inhibitor and has demonstrated excellent brain penetrance and activity in brain tumors. The clinical benefits of abemaciclib in other diseases (i.e., advanced breast cancer) are well-documented.
In this randomized clinical trial, participants will be randomly assigned to one of two treatment arms at a ratio of 2:1. This means that twice as many patients will receive abemaciclib as those who receive the placebo. Randomization will help the researchers study how the drug works by comparing the difference between the experimental treatment and the placebo with minimum bias.
Meningioma Trial Details
Recruiting
Abemaciclib
Placebo
Newly Diagnosed Grade 3 Meningioma
72 Participants
Ivy Brain Tumor Center
You may be eligible if:
- You are 18 years or older.
- You have a newly diagnosed intracranial WHO grade 3 meningioma or a meningioma that was previously lower grade but has progressed to WHO grade 3.
- You plan on following the standard treatment regimen, including surgical resection and radiation.
View all eligibility criteria by visiting ClinicalTrials.gov or call 602-406-8605 to speak with a patient navigator.
HOW IT WORKS
A patient with newly diagnosed grade 3 meningioma undergoes tumor resection (removal surgery) and approximately six weeks of radiation therapy as part of standard of care. Their resected tumor tissue is screened for a tumor-suppressive gene called retinoblastoma protein (Rb).
If the tumor is Rb positive, the patient is enrolled in the Phase 2 study two to five weeks following radiation and randomly assigned to receive either abemaciclib or placebo. Neither the patients nor the study team will know which treatment the patient is assigned to.
The study drug will be administered orally every day for 28-day cycles and will continue until the patient meets criteria for discontinuation.
For the initial two cycles, the patient will need to visit the clinic for monitoring while taking the study drug. For all subsequent cycles, they will be requested to come in on the first day of each 28-day cycle.
Am I Eligible?
Submit a no-cost trial screening request today to learn if you may qualify for a clinical trial or talk to an Ivy Navigator by calling 602-406-8605.
