NCT04980872View on ClinicalTrials.gov

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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 2, 2021

Primary Completion Date

February 7, 2030

Study Completion Date

February 7, 2030

Conditions
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
Interventions
DRUG

Miransertib

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

Trial Locations (11)

2305

John Hunter Hospital ( Site 0203), Newcastle

4670

Bundaberg Base Hospital ( Site 0202), Bundaberg

30322

Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107), Atlanta

45229

Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102), Cincinnati

77030

Texas Children's Hospital ( Site 0104), Houston

98105

Seattle Children's Hospital ( Site 0103), Seattle

74605070

Hospital Araújo Jorge ( Site 0801), Goiânia

02115

Boston Children's Hospital ( Site 0089), Boston

00168

Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052), Rome

00165

Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087), Rome

WC1N 3JH

Great Ormond Street Hospital ( Site 0701), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY