clinical trial · 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)
Merck Sharp & Dohme LLC·phase2·active not recruiting·n = 60
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)Miransertib
brief 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.
started
Nov 2, 2021
primary completion
Feb 7, 2030
completion
Feb 7, 2030
last updated
Feb 7, 2025
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol