NCT07407582 Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
| NCT ID | NCT07407582 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Arizona |
| Condition | Solid Tumor Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2026-07-30 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Participants have provided informed consent prior to initiation of any study-specific activities. * At least 18 years of age, male and female, at the time of signing the informed consent. * ECOG Performance Status 0-1 * Histologically or cytologically confirmed treatment-naïve cancer. * Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg/m2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician Exclusion Criteria: * Prior cisplatin exposure due to a cancer treatment history * Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative * Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin * History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components * Baseline serum sodium \> 145 mmol/L or any grade ≥ 3 electrolyte abnormality * Cisplatin infusion duration greater than 6 hours * Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment * Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment * Subject likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Contact & Investigator
Lisa Davis, PharmD
STUDY CHAIR
University of Arizona
Frequently Asked Questions
Who can join the NCT07407582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07407582 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07407582 currently recruiting?
Yes, NCT07407582 is actively recruiting participants. Contact the research team at areciomd@arizona.edu for enrollment information.
Where is the NCT07407582 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT07407582 clinical trial?
NCT07407582 is sponsored by University of Arizona. The principal investigator is Lisa Davis, PharmD at University of Arizona. The trial plans to enroll 25 participants.