drugset / Trial / NCT03393000
Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-01-16
- Primary completion
- 2020-11-06
- Completion
- 2020-11-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trans Sodium Crocetinate | Other / unclassified | 0.25 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Trans Sodium Crocetinate | Other / unclassified | 1.5 mg/kg | Intravenous |
| Background | Temozolomide | Small molecule | 200 mg/m2 | Oral |