Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pedmark® STS
DrugPedmark® 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Study Treatment ArmExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.Secondary outcomes
1
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.
Time frame
At the end of treatment, up to 12 months from baseline.2
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).
Time frame
At the end of treatment, up to 12 months from baseline.3
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.
Time frame
At the first study treatment visit4
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.
Time frame
At the first study treatment visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
Fennec Pharma
Collaborator
Source ClinicalTrials.gov