Abemaciclib for Brain Cancer

Recruiting in Philadelphia (<50 mi)

Overseen by Stephen Bagley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stephen Bagley, MD, MSCE

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase II, single arm, open label study looking how well a drug called abemaciclib works in patients with recurrent oligodendroglioma

Eligibility Criteria

Adults with recurrent oligodendroglioma, confirmed by specific molecular markers (1p/19q codeletion), who have had prior radiation and chemotherapy can join. They must be able to take oral meds, have a life expectancy over 3 months, good performance status, and adequate organ function. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

My oligodendroglioma has worsened after radiation and chemotherapy.

My liver tests are within the required range for the study.

I have waited the required time after my last cancer treatment before joining this trial.

Exclusion Criteria

I do not have an active infection or HIV, and my hepatitis is not currently active.

I am not pregnant or breastfeeding.

Women must agree not to breast feed while on abemaciclib treatment and for at least three months following the last dose of study therapy

Treatment Details

Interventions

• Abemaciclib (CDK4/6 Inhibitor)

Trial Overview The trial is testing the effectiveness of abemaciclib at a dose of 200 MG in patients with recurrent oligodendroglioma. It's an open-label study where all participants receive the drug to see how well it works against this type of brain tumor.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity.

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:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

Stephen Bagley, MD, MSCE Lead Sponsor

Abramson Cancer Center at Penn Medicine Collaborator

University of Pennsylvania Collaborator

Abramson Cancer Center of the University of Pennsylvania Collaborator

References