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

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.

Trial Details

NCT ID
NCT07407582
Phase
PHASE1 / PHASE2
Sponsor
University of Arizona
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Pedmark® STS
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648

Key Eligibility Criteria

  • Participants have provided informed consent prior to initiation of any study-specific activities.
  • At least 18 years of age, male or female, at the time of signing the informed consent.
  • ECOG Performance Status 0-1
  • Histologically or cytologically confirmed treatment-naïve cancer.

For full eligibility, visit ClinicalTrials.gov.

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