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NOT YET RECRUITING
NCT07407582
PHASE1/PHASE2

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

Sponsor: University of Arizona

View on ClinicalTrials.gov

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.

Official title: Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-04-30

Completion Date

2028-04-30

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

Pedmark® STS

Pedmark® STS (20 g/m2) will be given via intravenous infusion over 15-30 minutes, starting 6 hours after the completion of cisplatin infusion. Pedmark® STS will be given each day of cisplatin infusion.

Locations (1)

University of Arizona Cancer Center

Tucson, Arizona, United States