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ACTIVE NOT RECRUITING
NCT04980872
PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-11-02

Completion Date

2030-02-07

Last Updated

2025-02-07

Healthy Volunteers

No

Interventions

DRUG

Miransertib

Miransertib capsules administered orally either 1 hour before or 2 hours after a meal.

Locations (11)

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

Great Ormond Street Hospital ( Site 0701)

London, London, City of, United Kingdom