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NCT03796273 · ClinicalTrials.gov registry record · Early Phase 1
Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
NCT03796273: Clinical Trial Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03796273 is a Early Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 15 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796273, a Early Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.
Primary Outcome
The primary outcome of this study is modulation of the tGLI1 pathway as assessed by the tGLI1 activation signature 8 (t-GAS 8) \[29, 40\]. t-GAS 8 consists of eight validated tGLI1 regulated genes (CD24, CD44, VEGF-A, VEGF-C, VEGFR2, TEM7, OCT-4. and heparanase) and is measured using qPCR in patients whose brain tissue expresses tGLI1 (by IHC). The distribution of the tGAS will be examined and transformed to approximate the conditional normality assumption if necessary. Analysis of variance (ANO
Interventions
- OTHER Best Practice
- DRUG Ketoconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-03-13 |
| Est. Completion | 2022-10-23 |
| Phase | Early Phase 1 |
Why NCT03796273 stopped before completion
NCT03796273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Best Practice is the first listed.
NCT03796273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03796273 about?
NCT03796273 is a clinical study titled "Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases". This trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.
What is the current status of trial NCT03796273?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2019-03-13. Estimated completion is 2022-10-23.
What interventions are being tested in trial NCT03796273?
The interventions under investigation include: Best Practice (OTHER), Ketoconazole (DRUG).
Who is sponsoring clinical trial NCT03796273?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03796273's enrollment target sits among peer trials
15 1403rd of 2000 higher than 527 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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