ACTR-45. PHASE 0/2 STUDY OF RIBOCICLIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA

ABSTRACT: Abstract

BACKGROUND

CDK4/6-dependent cell-cycle regulation is disrupted in 78% of glioblastoma patients. We conducted a Phase 0/2 clinical trial (NCT02933736) of ribociclib, a selective CDK4/6-inhibitor, to examine the plasma and tumor pharmacokinetics (PK) and pharmacodynamics (PD) of recurrent glioblastoma.

METHODS

Eligible patients with intact RB expression and CDKN2A deletion or CDK4/6 amplification were enrolled into the Phase 0 component to receive ribociclib (900mg daily) for 5 days prior to tumor resection. Plasma, tumor, and CSF samples were collected to determine drug concentrations using validated LC-MS/MS methods. PD effects, including RB and FoxM1 phosphorylation, were compared to archival tissue. Patients with favorable PK and PD outcomes were transitioned i

SUBMITTER: Tien A 

PROVIDER: S-EPMC6216383 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature