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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: Completed Early Phase 1 study, sponsored by Duke University.
NCT04937413 is a Early Phase 1 study that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determined by mass spectrometry
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 |
What the finished NCT04937413 record still lists
NCT04937413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT04937413 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04937413's enrollment target sits among peer trials
32 775th of 2000 higher than 1,208 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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