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NCT05521984 · ClinicalTrials.gov registry record · Phase 1
Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
A Phase 1 study of Pediatric Solid Tumor and Pediatric Brain Tumor, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05521984 is a Phase 1 study of Pediatric Solid Tumor and Pediatric Brain Tumor that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 1,131-participant average among 10 other Pediatric Solid Tumor trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05521984, a Phase 1 study of Pediatric Solid Tumor and Pediatric Brain Tumor, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Topotecan
- DRUG Carmustine
- DRUG Dapagliflozin
Study Locations (1)
Missouri
- Washington University School of Medicine/St. Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05521984
The ClinicalTrials.gov registry entry for NCT05521984 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,131-participant average among 10 other Pediatric Solid Tumor trials with a reported enrollment target (98% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pediatric Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05521984 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05521984 about?
NCT05521984 is a clinical study titled "Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)". 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 p...
What is the current status of trial NCT05521984?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-04-03. Estimated completion is 2026-11-30.
What conditions does trial NCT05521984 study?
This clinical trial studies the following conditions: Pediatric Solid Tumor, Pediatric Brain Tumor.
What interventions are being tested in trial NCT05521984?
The interventions under investigation include: Cyclophosphamide (DRUG), Topotecan (DRUG), Carmustine (DRUG), Dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT05521984?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05521984 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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