Summary:
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 0/2 clinical trial to evaluate the combination of two targeted therapies, abemaciclib (a CDK4/6 inhibitor) and LY3214996 (an ERK inhibitor), in patients with recurrent glioblastoma. It is the first time this newly-developed drug combination will be tested in brain tumor patients.
The goal of this study is to confirm that both drugs are capable of crossing the blood-brain barrier. Patients with positive results may continue to receive treatment in a Phase 2 study arm. We will also confirm if the study drugs are hitting the molecular targets.
- CDK4/6, or cyclin-dependent kinase 4 and 6, are two proteins found in cells that accelerate growth and division. Abemaciclib, a CDK4/6 inhibitor, has the ability to block these proteins and prevent tumor cells from dividing.
- ERK proteins transmit a signal from the surface of a cell to the nucleus that triggers cell division. LY3214996, an ERK1/2 inhibitor, is a small-molecule drug that can stop the signal and block cancer cell growth.
- Abemaciclib is FDA approved for the treatment of breast cancer.
Criteria:- Be 18 years or older
- Have had prior resection (surgical removal) of a histologically diagnosed WHO grade IV glioma
- Have been treated with radiation and a chemotherapy drug called temozolomide
- Have been told by a doctor that their tumor has recurred (come back) or has progressed (grown or changed)