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Идёт набор NCT05865028

A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

Фаза II С лечением Oropharyngeal Dysplasia Oral Cavity Dysplasia Oral Carcinoma in Situ

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: APG-157.
Кому может быть актуально
Состояния в реестре: Oropharyngeal Dysplasia, Oral Cavity Dysplasia, Oral Carcinoma in Situ. 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 II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

Обзор

The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.

Вмешательства

  • Препарат APG-157
    Participants will take 200mg (2 x 100mg pastilles) of APG-157 therapy orally (PO) three times daily during each 4-week cycle for up to three cycles. Cycle three is optional.

Первичные конечные точки

  • Pathologic Response Rate [Срок оценки: Up to 12 weeks]
Вторичные конечные точки (3)
  • Clinical Response Rate [Срок оценки: Up to 12 weeks]
  • Change in Lesion Appearance Before and After Protocol Therapy [Срок оценки: Baseline, 12 weeks post-intervention, Up to 28 months]
  • Number of Treatment-Related Adverse Events and Serious Adverse Events [Срок оценки: Up to 16 weeks]

Критерии участия

Критерии включения

  • Adult patients age > 18 years with biopsy-proven moderate to severe oral dysplasia or carcinoma in situ (CIS) and a visible lesion. Sites include all oral cavity as well as oropharyngeal dysplasia that is accessible in the outpatient clinic.
  • Histologically proven oral cavity or oropharyngeal moderate or severe dysplasia/CIS as diagnosed by standard pathological methods and a visible lesion on oral exam.
  • Measurable disease - minimum lesion size of 8 x 3 mm before initial biopsy
  • Willing to provide blood, oral rinse and tissue from diagnostic biopsies
  • Leukocytes >=3,000/microliter
  • Absolute neutrophil count >= 1,000/microliter, Platelets >= 100,000/microliter, Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), aspartate aminotransferase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) and serum glutamic pyruvic transaminase (SGPT) =< 1.5 x institutional upper limit of normal (ULN). Exceptions to this Inclusion Criteria can be made if labs are deemed not clinically significant by the principal investigator (PI).
  • Willing to use adequate contraception, subject or partner has had a vasectomy or partner is using effective birth control or is post-menopausal for the duration of the study.
  • Able to take oral medication.
  • Able to understand and the willingness to sign a written informed consent document.

Критерии исключения

  • Pregnant women.
  • Subjects who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks excluding biopsies and tooth extractions.
  • Subjects who have had a fracture of the mandible or maxilla within the previous 8 weeks.
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
  • History of prior head and neck squamous cell carcinomas (HNSCC) unless curatively treated 1 year or more prior.
  • Use of chemotherapy and/or radiation for any malignancy (excluding nonmelanoma skin cancer and cancer confined to organs with removal as only treatment) in the past 2 years.
  • Subjects with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.
  • History of allergic reactions attributed to compounds of similar chemical composition to Curcumin (turmeric).
  • Active or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension. Exceptions to this Exclusion Criteria can be made if patient status is deemed not clinically significant by the PI.
  • Severe thrombocytopenia increasing the risk of biopsy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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 Miami — Miami

Идентификаторы

NCT: NCT05865028 · 20221112 · NCI-2023-04230

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗