drugset / Trial / NCT03778996
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts: * Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment * Clinically advanced sarcoma patients in the salvage treatment setting Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations.
Timeline
- Start
- 2020-01-03
- Primary completion
- 2027-12-19
- Completion
- 2028-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D,L-alpha-metyrosine | Unknown | — | Oral |
| Subject | Methoxsalen | Other / unclassified | — | Oral |
| Subject | Phenytoin | Unknown | — | Oral |
| Subject | Sirolimus | Small molecule | — | Oral |