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
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)