Magnetic resonance imaging (MRI) of the brain, brain tumor

Ly3214996 plus abemaciclib for glioblastoma

About the Glioblastoma
clinical trial

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. 

Glioblastoma Trial Details

Study Status

Recruiting

Treatment Agent(s)

Abemaciclib and LY3214996 

Diseases

Glioma, 

Glioblastoma 

Estimated Enrollment

50 Participants 

Clinicaltrials.gov identifier
Older patient listening to her physician

You may be eligible if:

  • You are 18 years or older
  • You have had prior resection (surgical removal) of a histologically diagnosed high-grade glioma (III and IV)
  • You have been treated with radiation and a chemotherapy drug called temozolomide
  • Your doctor has told you that your tumor has recurred (come back) or has progressed (grown or changed)
  • You have enough archival tumor tissue available from previous surgery to conduct genetic testing for the presence of FGFR3-TACC3 fusion gene or mutations in the FGFR1 and 3 genes.

How it works

Icon of Brain Tumor Patient

Once enrolled, a patient receives a very small exposure to the experimental therapy days before a planned operation to remove their tumor.


Glioblastoma Tumor Illustration

This exposure is enough that when we remove the tumor, our team of experts can ask two important questions: 

  1. Did the treatment penetrate the tumor? 
  2. Did the treatment have its intended effect? 

Combination Therapy for Gliboblastoma

If the drug penetrates the tumor at sufficient levels, the patient may move forward with receiving a full dose of the treatment – advancing to a Phase 2 clinical trial. 


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Alternatively, if the treatment has no effect on the tumor, the patient can enroll in another clinical trial without losing time or receiving ineffective treatment.


Am I Eligible?

Submit a free trial screening request today to learn if you may qualify for any of our studies.

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