drugset / Trial / NCT05521984
Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Phase 1
Recruiting
20 enrolled
Washington University School of Medicine
Children's Discovery Institute · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a pilot phase Ib study of the safety of dapagliflozin (in addition to standard of care treatment) for the treatment of pediatric patients with recurrent brain tumors and relapsed/refractory solid tumors. The primary hypothesis is that dapagliflozin is well-tolerated and safe to use in this patient population. The investigators also hypothesize that dapagliflozin will be efficacious as an adjunct to front-line chemotherapy assessed by decreased tumor markers mediated by its pleiotropic metabolic effects.
Timeline
- Start
- 2023-04-03
- Primary completion
- 2031-03-31
- Completion
- 2031-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 5 mg | Oral |
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Topotecan | Small molecule | — | — |
| Background | carmustine | Small molecule | — | — |