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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)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: A Multicenter, Open-label, Phase 2, Extension Trial to Study the Long-term Safety in Participants With PROS or Proteus Syndrome Who Are Currently Being Treated With Miransertib in Other Studies
Key Details
Gender
All
Age Range
2 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-11-02
Completion Date
2030-02-07
Last Updated
2025-02-07
Healthy Volunteers
No
Interventions
Miransertib
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
Locations (11)
Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107)
Atlanta, Georgia, United States
Boston Children's Hospital ( Site 0089)
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102)
Cincinnati, Ohio, United States
Texas Children's Hospital ( Site 0104)
Houston, Texas, United States
Seattle Children's Hospital ( Site 0103)
Seattle, Washington, United States
John Hunter Hospital ( Site 0203)
Newcastle, New South Wales, Australia
Bundaberg Base Hospital ( Site 0202)
Bundaberg, Queensland, Australia
Hospital Araújo Jorge ( Site 0801)
Goiânia, Goiás, Brazil
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052)
Rome, Lazio, Italy
Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087)
Rome, Roma, Italy
Great Ormond Street Hospital ( Site 0701)
London, London, City of, United Kingdom