Could a cancer pill slow aggressive brain tumors?
NCT ID NCT05940493
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug abemaciclib can help people with a fast-growing type of brain tumor called grade 3 meningioma. Participants will receive either the drug or a placebo after standard radiation therapy. The goal is to see if the drug delays tumor growth. About 72 people will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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St. Joseph's Hospital and Medical Center
RECRUITINGPhoenix, Arizona, 85013, United States
Contact Email: •••••@•••••
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