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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.
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
...and 1 more locations
Number of participants experiencing a Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An SAE can therefore be any such event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalizations, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is considered by the investigator to be an important medical event.
Time frame: Up to approximately 94 months
Number of participants discontinuing study treatment due to an Adverse Event (AE)
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality.
Time frame: Up to approximately 90 months
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