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Идёт набор NCT04945330

NTRK Gene Fusion - Positive Advanced or Recurrent Solid Tumors, a Rare Cancer Caused by Specific Changes in the Genes

— Наблюдательное Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

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: Larotrectinib (Vitrakvi, BAY2757556).
Кому может быть актуально
Состояния в реестре: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion. Базовые параметры: Без ограничений · 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
Япония
Следующий шаг
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Официальное название

Special Drug Use Investigation for Larotrectinib

Обзор

Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing. In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The study will include patients of all ages with TRK fusion cancer. In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from: * the patients' medical records * interviews with the patients or their parents or guardians * the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.

Вмешательства

  • Препарат Larotrectinib (Vitrakvi, BAY2757556)
    Follow clinical practice

Первичные конечные точки

  • Severity of treatment emergent adverse events (TEAEs) [Срок оценки: Approximate 8 years]
  • Frequency of TEAEs [Срок оценки: Approximate 8 years]
  • Seriousness of TEAEs [Срок оценки: Approximate 8 years]
  • Outcome of TEAEs [Срок оценки: Approximate 8 years]
  • Causality assessment of TEAEs [Срок оценки: Approximate 8 years]
Вторичные конечные точки (12)
  • Overall response rate (ORR), based on investigator assessment preferably using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate by local investigator assessment [Срок оценки: Approximate 8 years]
  • Disease control rate (DCR) [Срок оценки: Approximate 8 years]
  • Duration of response (DOR) [Срок оценки: Approximate 8 years]
  • Time to response (TTR) [Срок оценки: Approximate 8 years]
  • Progression-free survival (PFS) [Срок оценки: Approximate 8 years]
  • Overall survival (OS) [Срок оценки: Approximate 8 years]
  • Total dose [Срок оценки: Approximate 8 years]
  • Starting and ending dose [Срок оценки: Approximate 8 years]
  • Dose modification during treatment [Срок оценки: Approximate 8 years]
  • Duration of treatment (DOT) [Срок оценки: Approximate 8 years]
  • Baseline characteristics [Срок оценки: Approximate 8 years]
  • Neurological examination (normal/abnormal) [Срок оценки: Approximate 8 years]

Критерии участия

Критерии включения

  • Patients who are treated with larotrectinib or decided to be treated with larotrectinib, under routine clinical practice.

Критерии исключения

  • Participation in an investigational program with interventions outside of routine clinical practice

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 1 центр
  • Many locations — Multiple Locations

Идентификаторы

NCT: NCT04945330 · 21793

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗