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Активно (без набиране) Фаза 2 NCT04980872

A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 \[NCT03094832\] or ArQule CU/EAP \[NCT03317366\]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy.
Кой може да участва
Inclusion Criteria: * Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366) * For males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for ≥90 days after the last dose of study intervention * For females, is not pregnant or breastfeeding, and is either not a participant of childbearing potential (POCBP) or is a POCBP and is abstinent or uses a highly effective method of contraception Exclusion Criteria: * Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib * Has received other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule's CU/EAP and entering this trial * Is receiving systemic inhibitors of the mechanistic target of rapamycin (mTOR) pathway (eg, sirolimus, everolimus) * Is receiving immunosuppressive therapies * Is receiving continuous high dose steroids
Места на провеждане 5
Австралия (1)
John Hunter Hospital ( Site 0203)
Newcastle , New South Wales
Бразилия (1)
Hospital Araújo Jorge ( Site 0801)
Goiânia , Goiás
Италия (1)
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052)
Rome , Lazio
Великобритания (1)
Great Ormond Street Hospital ( Site 0701)
London , London, City of
САЩ (1)
Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107)
Atlanta , Georgia
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
120 Years
Здрави доброволци
Не
Начална дата
02.11.2021
Крайна дата
07.02.2030
Регистрационен номер
NCT04980872
Източник
anzctr
Запитване за медицински туризъм

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