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Активно (без набиране) Фаза 1/2 NCT04817007

A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis)

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Myelofibrosis

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.
Кой може да участва
Inclusion Criteria: * Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis * Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment * Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Women who are pregnant or breastfeeding at screening * Any significant acute or uncontrolled chronic medical illness Other protocol-defined inclusion/exclusion criteria apply
Места на провеждане 12
Австралия (1)
Local Institution - 0036
Blacktown , New South Wales
Франция (1)
Local Institution - 0030
Brest
Германия (1)
Local Institution - 0068
Erding , Bavaria
Гърция (1)
Local Institution - 0061
Chaïdári , Attikí
Унгария (1)
Local Institution - 0073
Szeged , Csongrád megye
Израел (1)
Local Institution - 0086
Beersheba , Southern District
Италия (1)
Local Institution - 0003
Bologna
Полша (1)
Local Institution - 0077
Słupsk , Pomeranian Voivodeship
Румъния (1)
Local Institution - 0052
Bucuresti , Cluj
Южна Корея (1)
Local Institution - 0049
Seongnam , Kyǒnggi-do
Испания (1)
Local Institution - 0020
Badalona , Barcelona [Barcelona]
САЩ (1)
Local Institution - 0069
Newport Beach , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.03.2021
Крайна дата
31.05.2026
Регистрационен номер
NCT04817007
Източник
anzctr
Запитване за медицински туризъм

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