BridgeMD
New treatment option for Meningioma
Official title Abemaciclib in Newly Diagnosed Meningioma Patients
ClinicalTrials.gov ID: NCT05940493
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for meningioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if...
You likely can't join 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...
- Known active systemic bacterial infection (requiring IV antibiotics at time of initiating study treatment), fungal infection, or detectable viral...
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.