Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Study Treatment Arm
Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion.
干预措施: Pedmark® STS (Drug)
结局指标
主要结局
Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin
时间窗: 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.
次要结局
- Cisplatin pharmacokinetics: elimination rate constant(At the first study treatment visit)
- 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: half-life(At the first study treatment visit)
- Cisplatin pharmacokinetics: total body clearance(At the first study treatment visit)