The Ivy Brain Tumor Center at Barrow Neurological Institute announced that patient recruitment has opened for a new Phase 0 clinical trial to evaluate two targeted therapy drugs, abemaciclib and LY3214996. The study will evaluate central nervous system (CNS) penetration in patients with recurrent glioblastoma scheduled for resection. This is the first time a combination of these two drugs will be tested in brain tumor patients.
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 from dividing.
ERK proteins transmit a signal from the surface of a cell to the nucleus that triggers division. LY3214996, an ERK1/2 inhibitor, is a small-molecule drug that can stop the signal and block cancer cell growth.
“The goal of this study is to confirm that both abemaciclib and LY3214996 are uniquely capable of crossing the blood-brain barrier and effectively hitting their molecular targets in the patient tumor cells. By blocking alternate escape routes, we hope to see this drug cocktail provide survival benefit in patients with the appropriate genetic markers,” said Shwetal Mehta, Ph.D., deputy director of the Ivy Brain Tumor Center.
The Ivy Center’s innovative Phase 0 clinical trials program has evolved the traditional Phase 0 design by incorporating a ‘trigger’ that advances brain tumor patients into a therapeutic Phase 2 study arm if the drugs are having the desired effects in an individual patient.
“Time is the most important commodity for brain tumor patients. At the Ivy Center, we can identify evidence of drug effects within 10 days of surgery, allowing the patient to either move forward with the experimental drug cocktail or enroll in another clinical trial without losing time,” said Nader Sanai, MD, director of the Ivy Brain Tumor Center.
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