The Ivy Brain Tumor Center at the Barrow Neurological Institute recently completed a Phase 0 clinical trial of the breast cancer drug ribociclib (Kisqali) for the treatment of recurrent glioblastoma. The Ivy recently received $50 million to combat brain cancer. This new drug cocktail represents one of the potential weapons in humankind's war against this killer disease.
The study assessed the central nervous system (CNS) pharmacokinetics and tumor pharmacodynamics of ribociiclib, a highly selective CDK4/6-inhibitor, in patients with recurrent glioblastoma.
The study team design included recurrent glioblastoma patients with intact retinoblastoma protein (RB) expression and CDKN2A deletion or CDK4/6 amplification, which were treated with ribociclib daily (900 mg) for 5 days total and unbound ribociclib concentrations were determined. Pharmacodynamic effects, assessed by RB and FOXM1 phosphorylation, were compared to matched archival tissue. Patients with positive pharmacokinetic and pharmacodynamic effects were enrolled in the expansion cohort for preliminary assessment of progression-free survival (PFS).
Twelve patients were enrolled. The mean unbound ribo...
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