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NCT03861598 · ClinicalTrials.gov registry record · Early Phase 1
Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells
A Early Phase 1 study, sponsored by West Virginia University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT03861598: Clinical Trial Early Phase 1 study, sponsored by West Virginia University.
NCT03861598 is a Early Phase 1 study that was terminated before completion, run by West Virginia University. The registered enrollment target is 4 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861598, a Early Phase 1 study, was terminated before completion, sponsored by West Virginia University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Subjects will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Carvedilol will start at 6.25 mg orally twice a day and be increased to 12.5 mg orally twice daily after 1 to 2 weeks if tolerated. Peripheral glioma circulating tumor cells (CTC) and brain MRI with and without contrast will be obtained at baseline, 2 cycles, and 4 cycles to determine the efficacy and direction of change of the CTC using a new assay tool. Preliminary assessment of the tolerability of Carvedilol with standard chemotherapy will also be evaluated.
Primary Outcome
Identify the correlation between our new RT-qPCR assay for circulating tumor cells and the change in responses in patients on treatment to MRI results. We will use 1 to indicate progression of disease seen on brain MRI, 2 to indicate stability or no change in imaging, and 3 to indicate response to treatment. The correlation will be assessed by Spearman's Rank Correlation coefficient. We will have six patients on this study which will give us 12 changed measurements.
Interventions
- DRUG Carvedilol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2021-06-17 |
| Phase | Early Phase 1 |
Why NCT03861598 stopped before completion
NCT03861598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Carvedilol is the first listed.
NCT03861598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03861598 about?
NCT03861598 is a clinical study titled "Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells". Subjects will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Carvedilol will start at 6.25 mg orally twice a day and be increased to 12.5 mg orally twice daily after 1 to 2 weeks if tolerated. Peripheral glioma circulatin...
What is the current status of trial NCT03861598?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2019-07-19. Estimated completion is 2021-06-17.
What interventions are being tested in trial NCT03861598?
The interventions under investigation include: Carvedilol (DRUG).
Who is sponsoring clinical trial NCT03861598?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861598's enrollment target sits among peer trials
4 1921st of 2000 higher than 53 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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