Abemaciclib in Newly Diagnosed Meningioma Patients

A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants

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 Overview

• Status: Recruiting
• Conditions: Meningioma
• Intervention / Treatment: Drug: Placebo; Drug: Abemaciclib

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ivy Research Navigator; Phone Number: 602-406-8605; Email: research@ivybraintumorcenter.org

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • St. Joseph's Hospital and Medical Center
      • Contact: Phase 0 Navigator; Phone Number: 602-406-8605; Email: research@ivybraintumorcenter.org
      • Principal Investigator: Nader Sanai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with newly diagnosed intracranial WHO Grade 3 meningioma; or,
• Participants with previous lower grade meningioma and histopathologically confirmed newly transformation to Grade 3.
• Plan to receive or have received upfront standard of care radiation therapy (RT) for the newly diagnosed WHO Grade 3 meningioma.
• No prior treatment for Grade 3 meningioma other than surgical resection or biopsy and upfront RT. If previously diagnosed with a lower grade meningioma, no prior treatment other than surgical resection or biopsy and no prior RT.
• Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
• Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative[s], and assent, if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally document and witnessed, ideally via an independent trusted witness. Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
• Age ≥18 years at time of consent.
• Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Ability to swallow oral medications.

• Participant has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):

  • Adequate Bone Marrow Function: absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, and hemoglobin ≥8.0 g/dL (individual may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must no begin earlier than the day after any erythrocyte transfusion).
  • Adequate Hepatic Function: total bilirubin ≤1.5x ULN (individuals with Gilbert's syndrome with a total bilirubin ≤2.0x ULN and direct bilirubin within normal limits are permitted), AST/SGOT ≤3x ULN, and ALT/SGPT ≤3x ULN.
• Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant who is no longer of childbearing potential due to surgical, chemical, or natural menopause.
• For females of reproductive potential: use of highly effective contraception during study participation and for an additional 3 weeks after the end of treatment administration.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner and for an additional 3 weeks after the end of treatment administration.

Exclusion Criteria:

• Prior history of cancer with ongoing treatment of disease.
• Pregnancy or breastfeeding.
• Known allergic reactions to components of the abemaciclib.
• Active infection or fever >38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.
• Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis.
• Known active systemic bacterial infection (requiring IV antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known HIV positivity or with known HBV or HCV). Screening is not required for enrollment.
• Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
• Prior therapy with any CDK4/6 inhibitor. Prior therapy is defined as therapeutic dosing.
• Treatment with another investigational drug within 5 half-lives of the investigational product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment (Abemaciclib); Administered twice daily on days 1-28 of each 28-day cycle.	Drug: Abemaciclib; Tablet
Placebo Comparator: Placebo; Administered twice daily on days 1-28 of each 28-day cycle.	Drug: Placebo; Tablet; Other Names: Abemaciclib placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival Characteristics Over 24 Months	Progression-free survival at 24 months (PFS24) will be analyzed using Kaplan-Meier methods.	Date of randomization to date of protocol-defined disease progression, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Drug-related Toxicities	Safety and tolerability of abemaciclib in participants with meningioma will be assessed.	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.	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.	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.	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.	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.	Date of randomization to date of death due to any cause, assessed up to 24 months
Median Overall Survival		Date of randomization to date of death due to any cause, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Nader Sanai
• Collaborators: Eli Lilly and Company; Barrow Neurological Institute; Ivy Brain Tumor Center
• Investigators: Principal Investigator: Nader Sanai, MD, Ivy Brain Tumor Center

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma; abemaciclib
• Other Study ID Numbers: 2021-14; 23-500-352-34-38 (Other Identifier: St. Joseph's Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No