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NCT03393000 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
A Phase 3 study, sponsored by Diffusion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT03393000: Clinical Trial Phase 3 study, sponsored by Diffusion Pharmaceuticals.
NCT03393000 is a Phase 3 study that was terminated before completion, run by Diffusion Pharmaceuticals. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393000, a Phase 3 study, was terminated before completion, sponsored by Diffusion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
Open-label, randomized, controlled, phase 3 safety and efficacy registration trial. Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care. The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.
Primary Outcome
Overall survival will be calculated from randomization to the time of death from any cause
Interventions
- OTHER Standard of Care (SOC)
- DRUG Trans Sodium Crocetinate plus SOC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 3 |
Why NCT03393000 stopped before completion
NCT03393000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT03393000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03393000 about?
NCT03393000 is a clinical study titled "Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects". Open-label, randomized, controlled, phase 3 safety and efficacy registration trial. Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care. The standard of care for GBM will consist of tem...
What is the current status of trial NCT03393000?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2018-01-16. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT03393000?
The interventions under investigation include: Standard of Care (SOC) (OTHER), Trans Sodium Crocetinate plus SOC (DRUG).
Who is sponsoring clinical trial NCT03393000?
This trial is sponsored by Diffusion Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03393000's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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