The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04937413
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab subcutaneous injection

Study Details

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.

Key Dates

Start date
Oct 8, 2021
Status verified
May 2024
Primary completion
Sep 13, 2023
Completion
Oct 12, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single dose of evolocumab
    420 mg of evolocumab subcutaneous injection 7-14 days before scheduled surgery for malignant glioma

Primary Outcome Measure

Presence of evolocumab in surgical tumor tissue and tissue from a matched control group [ Time Frame: At time of surgical resection ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Duke University Medical Center· Durham, NC

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