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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria revisedv6
  2. Start date changed from estimate of Jul 30, 2026 to May 18, 2026v5
  3. Recruitment opened
    • Start date: May 30, 2026 to Jul 30, 2026
    • Site details revised
    v4
  4. Start date: Apr 30, 2026 to May 30, 2026v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07407582
Lead Sponsor University of Arizona
Collaborators: Fennec Pharma
Conditions
(from sponsor)		 Solid Tumor Malignancies, Testicular Cancer, Head and Neck Cancer, Thoracic Cancer
Related terms Head and Neck Neoplasms, Hearing Loss, Neoplasms, Testicular Neoplasms
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov