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

NCT07407582 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00006997
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Cancer; Head and Neck Cancer; Thoracic Cancer; Solid Tumor Malignancies

Keywords

Cisplatin; Otoprotectant; Cancer; Hearing Impairment; Sodium Thiosulfate; Adults; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin

  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 threshold greater than or equal to 40 dB HL at 1 kHz and above.

  Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.

Secondary Outcomes (7)

• Tolerability of the administration of STS based on the adverse events

  At the end of treatment, up to 12 months from baseline.

• Tolerability of the administration of STS: emetic control.

  At the end of treatment, up to 12 months from baseline.

• Cisplatin pharmacokinetics: area under the plasma concentration versus time curve (AUC)

  At the first study treatment visit

• Cisplatin pharmacokinetics: peak plasma concentration (Cmax)

  At the first study treatment visit

• Cisplatin pharmacokinetics: elimination rate constant

  At the first study treatment visit

Study Arms (1)

Study Treatment Arm

EXPERIMENTAL

Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion.

Drug: Pedmark® STS

Interventions

Pedmark® STS DRUG

Pedmark® STS (20 g/m2) will be given via intravenous infusion over 15-30 minutes, starting 6 hours after the completion of cisplatin infusion. Pedmark® STS will be given each day of cisplatin infusion.

Study Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Fennec Pharma: collaborator

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Testicular Neoplasms; Head and Neck Neoplasms; Neoplasms; Hearing Loss

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Davis, PharmD

  University of Arizona

  STUDY CHAIR

• Alejandro Recio-Boiles, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Recio Boiles, MD

CONTACT

520-694-2873; areciomd@arizona.edu

Michele Chu-Pilli

CONTACT

520-626-1183; chum@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)