MeningiomaPhase 2NCT05940493
Abemaciclib in Newly Diagnosed Meningioma Patients
A Phase 2 study testing Abemaciclib in people with Meningioma, run by Nader Sanai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Phase 0 Navigator, 602-406-8605, research@ivybraintumorcenter.org
Nader Sanai, MD
About this study
Official title: 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.
- Conditions
- Meningioma
- Being tested
- Abemaciclib, Placebo
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Tablet
PlaceboDrug
Also called Abemaciclib placebo
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment (Abemaciclib) | Experimental | Administered twice daily on days 1-28 of each 28-day cycle. Receives: Drug: Abemaciclib |
| Placebo | Placebo comparator | Administered twice daily on days 1-28 of each 28-day cycle. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Characteristics Over 24 Months
Progression-free survival at 24 months (PFS24) will be analyzed using Kaplan-Meier methods.
Measured: Date of randomization to date of protocol-defined disease progression, assessed up to 24 months
Secondary outcomes (7)
Incidence of Drug-related Toxicities
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Date of randomization to date of death due to any cause, assessed up to 24 months
Median Overall Survival
Measured: Date of randomization to date of death due to any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start24 Mar 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Sanai
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Barrow Neurological Institute, Ivy Brain Tumor Center
- Responsible party
- Sponsor-investigator, Nader Sanai, St. Joseph's Hospital and Medical Center, Phoenix
- Investigators
- Nader Sanai, MD, Principal investigator, Ivy Brain Tumor Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940493
- Sponsor's protocol ID
- 2021-14
- Other IDs
- 23-500-352-34-38
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Double-blind, Randomized-controlled Study of Abemaciclib (CDK4 and 6 Inhibitor) in Newly Diagnosed RB-proficient Grade 3 Meningioma Participants
- ClinicalTrials.gov ID
- NCT05940493
- Acronym / sponsor ID
- 2021-14
- Conditions
- Meningioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nader SanaiUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Barrow Neurological Institute, Ivy Brain Tumor Center
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (Abemaciclib) | Experimental | Drug: AbemaciclibAdministered twice daily on days 1-28 of each 28-day cycle. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered twice daily on days 1-28 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibTablet | Drug | Active Treatment (Abemaciclib) |
| PlaceboAlso: Abemaciclib placeboTablet | Drug | Placebo |
Primary outcome
Progression-Free Survival Characteristics Over 24 Months
Time frame: Date of randomization to date of protocol-defined disease progression, assessed up to 24 months
Progression-free survival at 24 months (PFS24) will be analyzed using Kaplan-Meier methods.
7 secondary outcomes
Incidence of Drug-related Toxicities
Time frame: Date of first dose up to 30 days after last dose
Incidence of Adverse Events as Assessed by CTCAE v5.0
Time frame: Date of randomization up to 30 days after last dose
Incidence of Deaths
Time frame: 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
Time frame: Date of randomization up to 30 days after last dose
Progression-Free Survival Characteristics Over 12 Months
Time frame: Date of randomization to date of protocol-defined disease progression, assessed up to 12 months
Overall Survival Characteristics Over 24 Months
Time frame: Date of randomization to date of death due to any cause, assessed up to 24 months
Median Overall Survival
Time frame: Date of randomization to date of death due to any cause, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nader Sanai, MD principal investigator
Ivy Brain Tumor Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib in people with Meningioma, run by Nader Sanai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivy Research Navigator (602-406-8605, research@ivybraintumorcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.