The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
This Phase 0 surgical window of opportunity trial seeks to evaluate the pharmacokinetic (PK)
and pharmacodynamic (PD) properties of an FDA-approved proprotein convertase/ kexin type 9
serine protease inhibitor (PCSK9i) in patients with primary and recurrent World Health
Organization (WHO) grade IV malignant glioma. The investigators intend to evaluate whether a
clinically licensed PCSK9i called evolocumab (also known as Repatha) can be repurposed as a
potential immunotherapeutic for high grade glioma by testing its ability to access the
intracranial space. The primary objective is to evaluate whether evolocumab crosses the blood
brain barrier (BBB) and is measurable in the resected tumor specimens of patients with
primary and recurrent high grade glioma or glioblastoma.