Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
Recruiting
Phase 1
Phase 2
Interventional Study
Solid Tumor Malignancies
Testicular Cancer
Head and Neck Cancer
Thoracic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- University of Arizona · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion 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 …
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