Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

Exclusion Criteria

• •Part A:
• •History of Type 1 or 2 uncontrolled diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL (if \> 12 years old) and ≥ 180 mg/dL (if ≤ 12 years old) at the screening visit
• •History of significant cardiac disorders:
• •* Myocardial infarction (MI) or congestive heart failure defined as Class II-IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of miransertib (MI occurring \> 6 months of the first dose of miransertib will be permitted)
• •* Grade 2 (per NCI CTCAE version 4.03) or worse conduction defect (e.g., right or left bundle branch block); left ventricular ejection fraction (LVEF) \< 50% assessed by echocardiogram/multigated acquisition (MUGA) scan
• •Major surgery, radiotherapy, or immunotherapy within four weeks of the first dose of miransertib
• •Any experimental systemic therapy for the purpose of treating PROS or PS (e.g., sirolimus, everolimus, high dose steroids) within two weeks of the first dose of miransertib, except for participants who were previously or are currently treated with miransertib under a Compassionate Use/Expanded Access program
• •Intolerance of or severe toxicity attributed to v-Akt murine thymoma viral oncogene homolog (AKT) inhibitors (e.g., miransertib, uprosertib, afuresertib, ipatasertib)
• •Concurrent severe uncontrolled illness not related to PROS or PS (ongoing or active infection, known human immunodeficiency virus (HIV) infection, malabsorption syndrome, psychiatric illness/substance abuse/social situation that would limit compliance with study requirements)
• •Pregnant or breastfeeding
• •Inability to comply with study evaluations or to follow drug administration guidelines
• •Part B
• •History of Type 1 diabetes mellitus or Type 2 uncontrolled diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL (if \> 12 years old) and ≥ 180 mg/dL (if ≤ 12 years old) at the screening visit
• •History of significant cardiac disorders:
• •* Myocardial infarction (MI) or congestive heart failure defined as Class II-IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of miransertib (MI occurring \> 6 months of the first dose of miransertib will be permitted)
• •* Grade 2 (per current version of National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\]) or worse conduction defect (e.g., right or left bundle branch block)
• •* Major surgery or locoregional therapy within four weeks of the first dose of miransertib
• •Any experimental systemic therapy for the purposes of treating PROS or PS (e.g., sirolimus, everolimus, high dose steroids) within two weeks of the first dose of miransertib
• •Intolerance of or severe toxicity attributed to AKT inhibitors (e.g., miransertib, uprosertib, afuresertib, ipatasertib)
• •Concurrent severe uncontrolled illness not related to PROS or PS (e.g. ongoing or active infection, known HIV infection, malabsorption syndrome, psychiatric illness/substance abuse/social situation that would limit compliance with study requirements)
• •Pregnant or breastfeeding
• •Inability to comply with study evaluations or to follow drug administration guidelines