A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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: Bomedemstat.
- Кому может быть актуально
- Состояния в реестре: Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis. 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, Австралия, Гонконг, Италия, Новая Зеландия +1
- 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
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
Обзор
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.
Вмешательства
- Препарат Bomedemstat
10, 15, 20, and 50 mg oral capsules
Первичные конечные точки
- Percentage of participants with one or more adverse events (AEs) [Срок оценки: Up to ~10 years]
- Percentage of participants who discontinued study treatment due to an AE [Срок оценки: Up to ~10 years]
Вторичные конечные точки (6)
- For participants with ET or PV: Duration of clinicohematologic response [Срок оценки: Up to ~10 years]
- For participants with ET or PV: Duration of hematologic remission [Срок оценки: Up to ~10 years]
- For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML [Срок оценки: Up to ~10 years]
- For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML [Срок оценки: Up to ~10 years]
- For participants with MF, ET, or PV: Percentage of participants with thrombotic events [Срок оценки: Up to ~10 years]
- For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events [Срок оценки: Up to ~10 years]
Критерии участия
Критерии включения
- Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Is not currently on a dose hold
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Критерии исключения
- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator
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
Австралия · 6 центров
- Royal Prince Alfred Hospital ( Site 1003) — Camperdown
- Royal North Shore Hospital ( Site 1001) — St Leonards
- Sunshine Coast Hematology and Oncology Clinic ( Site 1006) — Buderim
- Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) — Southport
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) — Adelaide
- Monash Health ( Site 1004) — Clayton
США · 4 центра
- University of Michigan ( Site 6000) — Ann Arbor
- DUHS Duke Blood Cancer Center ( Site 6005) — Durham
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Compr — Columbus
- UPMC Hillman Cancer Center ( Site 6004) — Pittsburgh
Италия · 4 центра
- Azienda Ospedaliera Universitaria Careggi ( Site 2700) — Florence
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703) — Alessandria
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702 — Bologna
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701) — Varese
Великобритания · 4 центра
- Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402) — London
- Boston Pilgrim Hospital ( Site 3403) — Boston
- University College London Hospital ( Site 3400) — London
- Guy's & St Thomas' NHS Foundation Trust ( Site 3401) — London
Новая Зеландия · 2 центра
- North Shore Hospital-Department of Haematology ( Site 1401) — Auckland
- Aotearoa Clinical Trials ( Site 1400) — Auckland
Гонконг · 1 центр
- Queen Mary Hospital ( Site 1601) — Hksar
Идентификаторы
NCT: NCT06351631 · 3543-017 · 2023-506996-89-00 · U1111-1294-8621 · MK-3543-017