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Идёт набор NCT04641247

A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Фаза II С лечением Ovarian Neoplasms Breast Neoplasms

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: Niraparib.
Кому может быть актуально
Состояния в реестре: Ovarian Neoplasms, Breast Neoplasms. 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, Австрия, Канада, Дания, Франция +3
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

An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib

Обзор

This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

Вмешательства

  • Препарат Niraparib
    Niraparib tablets or capsules will be given once a day via the oral route.

Первичные конечные точки

  • Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) [Срок оценки: Up to 5 years]
  • Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status [Срок оценки: Up to 5 years]
  • Number of participants with clinically significant changes in hematology and clinical chemistry parameters [Срок оценки: Up to 5 years]
  • Number of participants with clinically significant changes in vital signs [Срок оценки: Up to 5 years]
  • Number of participants with clinically significant changes in physical examination [Срок оценки: Up to 5 years]
  • Number of participants with use of concomitant medications [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
  • Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.
  • Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective.
  • Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.
  • Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.

Критерии исключения

  • Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.
  • Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.
  • Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).

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 · 13 центров
  • GSK Investigational Site — Tucson
  • GSK Investigational Site — Encinitas
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Whittier
  • GSK Investigational Site — Jacksonville
  • GSK Investigational Site — Atlanta
  • GSK Investigational Site — Harvey
  • GSK Investigational Site — Boston
  • … и ещё 5 центров
Канада · 3 центра
  • GSK Investigational Site — Kelowna
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
Австрия · 2 центра
  • GSK Investigational Site — Graz
  • GSK Investigational Site — Vienna
Франция · 2 центра
  • GSK Investigational Site — Nantes
  • GSK Investigational Site — Nice
Испания · 2 центра
  • GSK Investigational Site — Madrid
  • GSK Investigational Site — Madrid
Дания · 1 центр
  • GSK Investigational Site — Odense C
Израиль · 1 центр
  • GSK Investigational Site — Haifa
Италия · 1 центр
  • GSK Investigational Site — Cremona

Идентификаторы

NCT: NCT04641247 · 213409 · 2020-002667-53 · 2023-506618-29

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗