drugset / Trial / NCT07407582
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Thiosulfate | Diagnostic / imaging agent | 20000 mg/m2 | Intravenous |