Health Trials

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 limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.

Eligibility criteria

Qualifiers

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 cancer.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pedmark® STS

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

1
University of Arizona Cancer Center85724, TucsonArizona, United States

Sponsors and collaborators

University of Arizona

Lead sponsor

Fennec Pharma

Collaborator

Source ClinicalTrials.gov