Abemaciclib in Newly Diagnosed Meningioma Patients

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT05940493
Phase
PHASE2
Status
Recruiting
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Conditions

  • Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Tablet
  • Placebo — DRUG
    Tablet

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment (Abemaciclib)
    Administered twice daily on days 1-28 of each 28-day cycle.
  • Placebo Comparator: Placebo
    Administered twice daily on days 1-28 of each 28-day cycle.

Primary Outcome Measure

Progression-Free Survival Characteristics Over 24 Months [ Time Frame: Date of randomization to date of protocol-defined disease progression, assessed up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Phase 0 Navigator
[email protected]
602-406-8605
Nader Sanai, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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