Solid Tumor MalignanciesPhase 1/2NCT07407582
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
A Phase 1/2 study testing Pedmark® STS in people with Solid Tumor Malignancies and Testicular Cancer, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Testicular Cancer, Head and Neck Cancer
- What is being tested?
- Pedmark® STS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 30 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
Alejandro Recio-Boiles, MD
About this study
Official title: Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (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 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.
- Being tested
- Pedmark® STS
- Keywords
- Cisplatin, Otoprotectant, Cancer, Hearing Impairment, Sodium Thiosulfate, Adults, Solid Tumor
- Medical subject headings
- Testicular Neoplasms, Head and Neck Neoplasms, Neoplasms, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedmark® STSDrug
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 group | Role | What they receive |
|---|---|---|
| Study Treatment Arm | Experimental | Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion. Receives: Drug: Pedmark® STS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Overall safety profile characterized by the type, frequency, severity, duration, and relationship to STS of any adverse events.
Measured: At the end of treatment, up to 12 months from baseline.
Tolerability of the administration of STS: emetic control.
Emetic control (episodes nausea and/or vomiting) will be documented during the clinic visit or hospital stay as per standard practice and assessed using the MASCC Antiemesis Tool (MAT).
Measured: At the end of treatment, up to 12 months from baseline.
Cisplatin pharmacokinetics: area under the plasma concentration versus time curve (AUC)
A noncompartmental pharmacokinetic analysis of total and unbound cisplatin will be performed with Phoenix WinNonlin v8.5 (Certara), using a linear method to calculate the area under the plasma concentration versus time curve (AUC) at 4 and 6 hours post-cisplatin dose at the first study treatment visit.
Measured: At the first study treatment visit
Cisplatin pharmacokinetics: peak plasma concentration (Cmax)
A noncompartmental pharmacokinetic analysis of total and unbound cisplatin will be performed with Phoenix WinNonlin v8.5 (Certara), using a linear method to calculate the peak plasma concentration (Cmax) at 4 and 6 hours post-cisplatin dose at the first study treatment visit.
Measured: At the first study treatment visit
Cisplatin pharmacokinetics: elimination rate constant
A noncompartmental pharmacokinetic analysis of total and unbound cisplatin will be performed with Phoenix WinNonlin v8.5 (Certara), using a linear method to calculate the elimination rate constant at 4 and 6 hours post-cisplatin dose at the first study treatment visit.
Measured: At the first study treatment visit
Cisplatin pharmacokinetics: half-life
A noncompartmental pharmacokinetic analysis of total and unbound cisplatin will be performed with Phoenix WinNonlin v8.5 (Certara), using a linear method to calculate the half-life at 4 and 6 hours post-cisplatin dose at the first study treatment visit.
Measured: At the first study treatment visit
Cisplatin pharmacokinetics: total body clearance
A noncompartmental pharmacokinetic analysis of total and unbound cisplatin will be performed with Phoenix WinNonlin v8.5 (Certara), using a linear method to calculate the total body clearance at 4 and 6 hours post-cisplatin dose at the first study treatment visit.
Measured: At the first study treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start18 May 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Fennec Pharma
- Responsible party
- Sponsor
- Investigators
- Lisa Davis, PharmD, Study chair, University of ArizonaAlejandro Recio-Boiles, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407582
- Sponsor's protocol ID
- STUDY00006997
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)
- ClinicalTrials.gov ID
- NCT07407582
- Acronym / sponsor ID
- STUDY00006997
- Keywords
- Cisplatin, Otoprotectant, Cancer, Hearing Impairment, Sodium Thiosulfate, Adults, Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Fennec Pharma
- Study start
- 18 May 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment Arm | Experimental | Drug: Pedmark® STSStudy participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedmark® STSPedmark® 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. | Drug | Study Treatment Arm |
Primary outcome
Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin
Time frame: Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.
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.
7 secondary outcomes
Tolerability of the administration of STS based on the adverse events
Time frame: At the end of treatment, up to 12 months from baseline.
Tolerability of the administration of STS: emetic control.
Time frame: At the end of treatment, up to 12 months from baseline.
Cisplatin pharmacokinetics: area under the plasma concentration versus time curve (AUC)
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: peak plasma concentration (Cmax)
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: elimination rate constant
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: half-life
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: total body clearance
Time frame: At the first study treatment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Davis, PharmD study chair
University of Arizona
Alejandro Recio-Boiles, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pedmark® STS in people with Solid Tumor Malignancies and Testicular Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Recio Boiles, MD (520-694-2873, areciomd@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin (time frame: Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.