drugset / Trial / NCT07407582

Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

NCT07407582

Phase 1/2 Recruiting 25 enrolled University of Arizona Fennec Pharma · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.

Timeline

Start
2026-05-18
Primary completion
2028-04-30
Completion
2028-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Thiosulfate Diagnostic / imaging agent 20000 mg/m2 Intravenous