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)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)

Interventions

Type	Name	Description
DRUG	Miransertib	Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.

Timeline

• Start date: 2021-11-02
• Primary completion: 2030-02-07
• Completion: 2030-02-07
• First posted: 2021-07-28
• Last updated: 2025-02-07

Locations

11 sites across 5 countries: United States, Australia, Brazil, Italy, United Kingdom

Regulatory

• FDA-regulated drug study