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Набор скоро начнётся NCT07485569

Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial

Фаза I С лечением Thyroid Cancer Stage IV Anaplastic Thyroid Cancer Differentiated Thyroid Cancer Poorly Differentiated Thyroid Carcinoma

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: Personalised treatment.
Кому может быть актуально
Состояния в реестре: Thyroid Cancer Stage IV, Anaplastic Thyroid Cancer, Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Carcinoma. 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
Список центров уточняется — проверьте первичный протокол.
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

Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial

Обзор

This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.

Подробное описание

Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness.

This study is testing a new personalized approach called network pharmacology-based drug repurposing. This concept uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target.

The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.

This is an exploratory, single-arm phase Ib trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor.

This study is funded by the EU horizon project Precision drug REPurpOsing For EUrope and the world (REPO4EU) under grant agreement No. 101057619

Вмешательства

  • Комбинированный продукт Personalised treatment
    The therapy will consist of (one or more) approved drugs.

Первичные конечные точки

  • Feasibility [Срок оценки: 12 weeks]
  • Safety [Срок оценки: 12 weeks]
Вторичные конечные точки (1)
  • Preliminary efficacy [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.
  • Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).
  • Measurable disease per RECIST 1.1
  • ECOG performance status ≤ 2
  • Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.

Критерии исключения

  • Inability to provide informed consent
  • Inability to obtain a (new) biopsy for molecular profiling
  • Pregnancy or breastfeeding.
  • Other active malignancies requiring therapy.
  • Neutropenia (ANC < 1.5 × 10⁹/L).
  • Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).

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

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Nogales C, Mamdouh ZM, List M, Kiel C, Casas AI, Schmidt HHHW. Network pharmacology: curing causal mechanisms instead of treating symptoms. Trends Pharmacol Sci. 2022 Feb;43(2):136-150. doi: 10.1016/j.tips.2021.11.004. Epub 2021 Dec 9. PMID 34895945

Идентификаторы

NCT: NCT07485569 · 2023-507214-28-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗