Actively Recruiting
Abemaciclib in Newly Diagnosed Meningioma Patients
Led by Nader Sanai · Updated on 2026-03-13
72
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
Sponsors
N
Nader Sanai
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abemaciclib in Newly Diagnosed Meningioma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with newly diagnosed intracranial WHO Grade 3 meningioma or with transformation from lower grade meningioma to Grade 3 confirmed by pathology
- Plan to receive or have received standard radiation therapy for newly diagnosed Grade 3 meningioma
- No prior treatment for Grade 3 meningioma other than surgery or radiation; if previously lower grade, no prior radiation
- Ability and willingness to sign informed consent personally or via legally authorized representative
- Age 18 years or older at time of consent
- Performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale
- Ability to swallow oral medications
- Adequate bone marrow function: neutrophils ≥1500/mcL, platelets ≥100,000/mcL, hemoglobin ≥8.0 g/dL
- Adequate liver function: total bilirubin ≤1.5 times upper limit of normal (ULN), AST/SGOT ≤3x ULN, ALT/SGPT ≤3x ULN
- Negative pregnancy test or no longer of childbearing potential
- For females of reproductive potential, use highly effective contraception during study and for 3 weeks after treatment
- For males of reproductive potential, use condoms or other effective contraception during study and for 3 weeks after treatment
You will not qualify if you...
- Prior history of cancer with ongoing treatment
- Pregnancy or breastfeeding
- Allergic reactions to abemaciclib components
- Active infection or fever over 38.5°C requiring systemic antibiotic, antifungal, or antiviral therapy within 4 weeks before Day 1
- Active or uncontrolled severe infection or liver disease such as cirrhosis or hepatitis
- Active systemic bacterial, fungal, or detectable viral infections (including HIV, HBV, HCV)
- Serious or uncontrolled preexisting medical conditions that would prevent study participation
- Prior therapy with any CDK4/6 inhibitor at therapeutic doses
- Treatment with another investigational drug within 5 half-lives of the study drug
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
Research Team
I
Ivy Research Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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