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Идёт набор NCT07303894

A Study of Isoquercetin in People With Ovarian Cancer

Фаза II С лечением Ovarian Cancer Epithelial Ovarian Cancer Serous Ovarian Tumor

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: Isoquercetin, Placebo.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Epithelial Ovarian Cancer, Serous Ovarian Tumor. 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

Randomized, Multi-dose, Placebo-controlled Phase 2 Trial of Oral Isoquercetin to Reduce Thrombin Generation in Ovarian Cancer

Обзор

The purpose of this study is to test whether isoquercetin can reduce markers in the blood that may indicate the risk of blood clots in people with ovarian cancer. The effects of isoquercetin will be compared with those of a placebo.

Вмешательства

  • Препарат Isoquercetin
    Cohort B and Cohort C will take isoquercetin
  • Другое Placebo
    Placebo

Первичные конечные точки

  • Level of PDI-sensitive, platelet-dependent thrombin generation measured as compared to baseline [Срок оценки: up to 6 weeks from baseline]

Критерии участия

Критерии включения

  • Participants must have histological- or cytological-confirmed ovarian cancer (epithelial, serous, or clear cell) and be receiving first-line chemotherapy (day 1 of isoquercetin should align with day 1 of cycle 1 or 2 of chemotherapy) for neoadjuvant, adjuvant, or advanced settings.
  • Minimum age 18 years
  • Life expectancy of greater than 6 months.
  • ECOG performance status <2
  • Participants must have preserved organ and marrow function as defined below:
  • Platelet count > 50,000/mcL
  • Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin < 3 x ULN without liver metastases and <5 x ULN in presence of liver metastases.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 X ULN without liver metastases and <5 x ULN in the presence of liver metastases.
  • Estimated creatinine clearance (CrCl >30 ml/min)
  • The effects of isoquercetin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

  • Prior history of documented venous thromboembolic event within the last 2 years (excluding central line associated events whereby patients completed anticoagulation)
  • Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
  • History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
  • Familial bleeding diathesis
  • Known diagnosis of disseminated intravascular coagulation (DIC)
  • Currently receiving anticoagulant therapy
  • Current daily use of aspirin, clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g ibuprofen > 800 mg daily or equivalent)
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known intolerance of (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).
  • Participants with known brain metastases
  • Pregnant women are excluded from this study because isoquercetin is a PDI inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with isoquercetin, breastfeeding should be discontinued if the mother is treated with isoquercetin.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 8 центров
  • Beth Israel Deaconess Medical Center (Data Collection Only) — Boston
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre

Идентификаторы

NCT: NCT07303894 · 25-060

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗