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NCT07407582 · ClinicalTrials.gov registry record · Phase 1
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
A Phase 1 study, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT07407582: Recruiting Phase 1 study, sponsored by University of Arizona.
NCT07407582 is a Phase 1 study that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07407582, a Phase 1 study, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Proportion of participants with Brock grade ≥1 hearing loss determined from audiometry exams. The Brock ototoxicity classification and grading scale are as follows: Grade 0 = hearing threshold less than 40 dB HL at all test frequencies; Grade 1 = hearing threshold greater than or equal to 40 dB HL at 8 kHz only; Grade 2 = hearing threshold greater than or equal to 40 db HL at 4kHz and above; Grade 3 = hearing threshold greater than or equal to 40 dB HL at 2 kHz and above; Grade 4 = hearing thres
Interventions
- DRUG Pedmark® STS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-05-18 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 1 |
What NCT07407582 shows while recruiting
NCT07407582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Pedmark® STS is the first listed.
NCT07407582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07407582 about?
NCT07407582 is a clinical study titled "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 app...
What is the current status of trial NCT07407582?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2026-05-18. Estimated completion is 2028-04-30.
What interventions are being tested in trial NCT07407582?
The interventions under investigation include: Pedmark® STS (DRUG).
Who is sponsoring clinical trial NCT07407582?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07407582's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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