Abemaciclib in Newly Diagnosed Meningioma Patients
ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNader Sanai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Abemaciclib
DrugTablet
Placebo
DrugTablet
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Active Treatment (Abemaciclib)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival Characteristics Over 24 Months
Progression-free survival at 24 months (PFS24) will be analyzed using Kaplan-Meier methods.
Time frame
Date of randomization to date of protocol-defined disease progression, assessed up to 24 monthsSecondary outcomes
1
Incidence of Drug-related Toxicities
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame
Date of first dose up to 30 days after last dose2
Incidence of Adverse Events as Assessed by CTCAE v5.0
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame
Date of randomization up to 30 days after last dose3
Incidence of Deaths
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame
Date of first dose to date of death due to any cause, assessed over 60 months4
Incidence of Clinical Laboratory Abnormalities as Assessed by CTCAE v5.0
Safety and tolerability of abemaciclib in participants with meningioma will be assessed.
Time frame
Date of randomization up to 30 days after last doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nader Sanai
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Sponsor institution
Eli Lilly and Company
Collaborator
Barrow Neurological Institute
Collaborator
Ivy Brain Tumor Center
Collaborator
Source ClinicalTrials.gov