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.
My tumor is a type of brain cancer called oligodendroglioma with specific genetic features.
My liver is functioning well, based on recent tests.
My oligodendroglioma has worsened after radiation and chemotherapy.
I am 18 years old or older.
I can care for myself but may need occasional help.
I can swallow pills.
My kidney function is within the required range for the study.
My tumor is confirmed as oligodendroglioma with 1p/19q codeletion.
Exclusion Criteria
I am not pregnant or breastfeeding.
I am not currently using any other cancer treatments or investigational drugs.
I do not have severe lung problems, major stomach surgery, Crohn's, ulcerative colitis, or chronic severe diarrhea.
I have a history of serious heart rhythm problems or sudden cardiac arrest.
I have been treated with a CDK4/6 inhibitor before.
I am not taking seizure medications like carbamazepine, phenytoin, or phenobarbital.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 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 nearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who is running the clinical trial?
Stephen Bagley, MD, MSCELead Sponsor
Abramson Cancer Center at Penn MedicineCollaborator
University of PennsylvaniaCollaborator
Abramson Cancer Center of the University of PennsylvaniaCollaborator