NCT05521984

Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Brain Tumor
• Pediatric Solid Tumor

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Commercially available
DRUG	Carmustine	Standard of care
DRUG	Topotecan	Standard of care
DRUG	Cyclophosphamide	Standard of care

Timeline

• Start date: 2023-04-03
• Primary completion: 2031-03-31
• Completion: 2031-06-30
• First posted: 2022-08-30
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study