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NCT04937413 · ClinicalTrials.gov registry record · Early Phase 1
The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation
A Early Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 32
- Enrollment target
NCT04937413 is a Early Phase 1 study that has completed, run by Duke University. The registered enrollment target is 32 participants.
The verdict
NCT04937413, a Early Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 32 participants
- Enrollment target
Study 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.
Interventions
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-10-08 |
| Est. Completion | 2023-10-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04937413
The ClinicalTrials.gov registry entry for NCT04937413 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT04937413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04937413 about?
NCT04937413 is a clinical study titled "The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation". 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 m...
What is the current status of trial NCT04937413?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2021-10-08. Estimated completion is 2023-10-12.
What interventions are being tested in trial NCT04937413?
The interventions under investigation include: Evolocumab (DRUG).
Who is sponsoring clinical trial NCT04937413?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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