Abemaciclib in Newly Diagnosed Meningioma Patients

NCT05940493 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-1423-500-352-34-38
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Meningioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of Drug-related Toxicities

  Date of first dose up to 30 days after last dose

• Incidence of Adverse Events as Assessed by CTCAE v5.0

  Date of randomization up to 30 days after last dose

• Incidence of Deaths

  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

  Date of randomization up to 30 days after last dose

• Progression-Free Survival Characteristics Over 12 Months

  Date of randomization to date of protocol-defined disease progression, assessed up to 12 months

Study Arms (2)

Active Treatment (Abemaciclib)

EXPERIMENTAL

Administered twice daily on days 1-28 of each 28-day cycle.

Drug: Abemaciclib

Placebo

PLACEBO COMPARATOR

Administered twice daily on days 1-28 of each 28-day cycle.

Drug: Placebo

Interventions

Abemaciclib DRUG

Tablet

Active Treatment (Abemaciclib)

Placebo DRUG

Tablet

Also known as: Abemaciclib placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nader Sanai: lead
• Eli Lilly and Company: collaborator
• Barrow Neurological Institute: collaborator
• Ivy Brain Tumor Center: collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Nader Sanai, MD

  Ivy Brain Tumor Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivy Research Navigator

CONTACT

602-406-8605; research@ivybraintumorcenter.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All site study personnel, except the unblinded dispenser and verifier, will be aware of whether participants are receiving abemaciclib or placebo until the study is formally unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer/Director of the Ivy Brain Tumor Center

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: March 24, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)