Abemaciclib for Glioblastoma

Palo Alto (17 mi)

Eudocia Q. Lee, MD, MPH - Dana-Farber ...

Overseen byEudocia Q Lee, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This research study is studying a targeted therapy as a possible treatment for recurrent glioblastoma (GBM). The following intervention will be used in this study: -Abemaciclib

Eligibility Criteria

Adults with recurrent glioblastoma who can take oral medication and adhere to the study schedule. They must have specific genetic markers (CDK4/6 amplification, wild-type RB status), a Karnofsky Performance Status of at least 60, and be able to provide tissue samples for research. Women must test negative for pregnancy and agree to contraception; men also need to use birth control.

Inclusion Criteria

I can care for myself but may need occasional help.

My brain tumor has been confirmed as a specific type by a specialized lab review.

I am at least 18 years old.

I have genetic test results from a certified lab.

My brain cancer has returned for the first time.

Exclusion Criteria

I have been treated with drugs targeting VEGF.

My cancer has an IDH1 or IDH2 mutation.

I have been treated with a CDK4/6 inhibitor before.

My tumor has a 1p/19q co-deletion.

Treatment Details

The trial is testing Abemaciclib, a targeted therapy drug, on patients with recurrent glioblastoma after surgery. The aim is to see if this drug can effectively treat the cancer by focusing on certain genetic characteristics of the tumor cells.

3Treatment groups

Experimental Treatment

Group I: Cohort 1 Surgery ArmExperimental Treatment2 Interventions

Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.

Group II: Abemaciclib without SurgeryExperimental Treatment1 Intervention

* Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days. * NOTE: enrollment to this arm is complete

Group III: Abemaciclib with SurgeryExperimental Treatment2 Interventions

* Abemaciclib will be administered on a continuous twice daily dosing schedule * Patients who require re-operation will receive a short preoperative course of Abemaciclib * Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier. * After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days. * NOTE: enrollment to this arm is complete

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: