Study on Abemaciclib for Newly Diagnosed Meningioma Patients

Sponsor: Nader Sanai

Sponsor score: 0

ClinicalTrials ID:NCT05940493

Provider View

This clinical trial is exploring how the drug abemaciclib, which is not yet approved for brain tumors, can help treat patients with newly diagnosed grade 3 meningioma. Participants will be randomly assigned to receive either the study drug or a placebo after surgery and radiation therapy.

Patient Parameters

Program Overview

The purpose of this study is to investigate the effects of abemaciclib, a drug approved for other uses but not yet for brain tumors, in treating patients with newly diagnosed grade 3 meningioma. Participants will undergo surgery to remove tumor tissue, which will be tested for specific cell markers. If eligible, they will start the study treatment two to five weeks after completing standard radiation therapy. This is a randomized and double-blinded trial, meaning participants will be randomly assigned to receive either abemaciclib or a placebo, and neither the participants nor the researchers will know which treatment is being given. This helps ensure unbiased results in understanding how well the drug works compared to a placebo.

Eligibility Criteria

Inclusion Criteria

  • Have a newly diagnosed grade 3 meningioma or a lower grade that has progressed to grade 3, and have received radiation therapy.
  • Tumor tissue must show specific cell markers (RB positivity) or no RB mutations.
  • Must wait 14 to 35 days after radiation therapy before starting the study treatment and be fully recovered from radiation effects.
  • Must understand and agree to sign a consent form to participate.
  • Must be willing to follow the study schedule, including visits, treatments, and tests.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating ability to carry out daily activities.
  • Must be able to swallow pills.
  • Must have adequate bone marrow and organ function.
  • Women must have a negative pregnancy test before starting treatment or be unable to become pregnant.
  • Women of childbearing potential must use effective birth control during the study and for 3 weeks after treatment.
  • Men must use condoms or other effective birth control methods with partners during the study and for 3 weeks after treatment.

Exclusion Criteria

  • Have another type of cancer that is currently being treated.
  • Currently using certain blood thinners (except heparin or similar medications).
  • Pregnant or breastfeeding.
  • Allergic to components of abemaciclib.
  • Have an active infection or fever over 38.5°C requiring treatment within 4 weeks before starting the study.
  • Have severe or uncontrolled infections or liver disease.
  • Have a serious medical condition that would prevent participation.
  • Have previously used any CDK4/6 inhibitor.
  • Have taken another investigational drug recently.
  • Have a history of certain heart conditions, such as fainting due to heart issues or abnormal heart rhythms.

Locations

FACILITYZIPCITYSTATE
St. Joseph's Hospital and Medical Center85013PhoenixArizona

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