Actively Recruiting
A Phase 2 Multicenter, Double-blind, Randomized-Controlled Study of Abemaciclib in Newly Diagnosed RB-Proficient Grade 3 Meningioma Patients
Led by Nader Sanai · Updated on 2026-03-13
72
Participants Needed
1
Research Sites
104 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
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.
CONDITIONS
Brief 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 histopathologically confirmed transformation to Grade 3 from a lower grade
- Plan to receive or have received upfront standard radiation therapy for the newly diagnosed Grade 3 meningioma
- No prior treatment for Grade 3 meningioma other than surgery and upfront radiation therapy
- Ability and willingness to sign informed consent
- Age 18 years or older at time of consent
- Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Ability to swallow oral medications
- Adequate bone marrow, liver, and organ function as defined by laboratory values
- Negative serum pregnancy test before treatment or participant no longer of childbearing potential
- Use of effective contraception during study and for 3 weeks after treatment end for females of reproductive potential
- Use of effective contraception during study and for 3 weeks after treatment end for males of reproductive potential
You will not qualify if you...
- Prior history of cancer with ongoing treatment
- Pregnancy or breastfeeding
- Known allergic reactions to abemaciclib components
- Active infection or fever over 38.5 0C requiring systemic therapy within 4 weeks of treatment start
- Active or uncontrolled severe infection or liver disease
- Known active systemic bacterial, fungal, or viral infection
- Serious or uncontrolled preexisting medical conditions that preclude study participation
- Prior therapy with any CDK4/6 inhibitor
- Treatment with another investigational drug within 5 half-lives of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Abemaciclib or placebo tablets twice daily on days 1-28 of each 28-day cycle.
Visits every 28 days during treatment cycles
Duration - Up to 60 months after treatment
Participants are monitored for safety and survival outcomes after treatment ends.
Periodic visits for up to 60 months
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
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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