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| Name | Class |
|---|---|
| Fennec Pharma | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment Arm | Experimental | Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of treatment, up to 12 months from baseline. |
| Tolerability of the administration of STS: emetic control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alejandro Recio Boiles, MD | Contact | 520-694-2873 | areciomd@arizona.edu | |
| Michele Chu-Pilli | Contact | 520-626-1183 | chum@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Davis, PharmD | University of Arizona | Study Chair |
| Alejandro Recio-Boiles, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Recruiting | Tucson | Arizona | 85724 | United States |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
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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). |
| 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. | 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. | 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. | 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. | 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. | At the first study treatment visit |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |