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Идёт набор NCT07407582

Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

Фаза I / Фаза II С лечением Solid Tumor Malignancies Testicular Cancer Head and Neck Cancer Thoracic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pedmark® STS.
Кому может быть актуально
Состояния в реестре: Solid Tumor Malignancies, Testicular Cancer, Head and Neck Cancer, Thoracic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)

Обзор

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.

Вмешательства

  • Препарат Pedmark® STS
    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.

Первичные конечные точки

  • Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin [Срок оценки: Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.]
Вторичные конечные точки (7)
  • Tolerability of the administration of STS based on the adverse events [Срок оценки: At the end of treatment, up to 12 months from baseline.]
  • Tolerability of the administration of STS: emetic control. [Срок оценки: At the end of treatment, up to 12 months from baseline.]
  • Cisplatin pharmacokinetics: area under the plasma concentration versus time curve (AUC) [Срок оценки: At the first study treatment visit]
  • Cisplatin pharmacokinetics: peak plasma concentration (Cmax) [Срок оценки: At the first study treatment visit]
  • Cisplatin pharmacokinetics: elimination rate constant [Срок оценки: At the first study treatment visit]
  • Cisplatin pharmacokinetics: half-life [Срок оценки: At the first study treatment visit]
  • Cisplatin pharmacokinetics: total body clearance [Срок оценки: At the first study treatment visit]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Arizona Cancer Center — Tucson

Идентификаторы

NCT: NCT07407582 · STUDY00006997

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗