drugset / 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)

NCT04980872

Phase 2 Active not recruiting 60 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-02
Primary completion
2030-02-07
Completion
2030-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Miransertib Small molecule 5 mg/m2 Oral
Subject Miransertib Small molecule 35 mg/m2 Oral

Indications