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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 is a Phase 3 study that was terminated before completion, run by Diffusion Pharmaceuticals. The registered enrollment target is 19 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03393000
The ClinicalTrials.gov registry entry for NCT03393000 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diffusion Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT03393000 reports 0 study locations.
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.
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