Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

April 11, 2022

Study Completion Date

April 11, 2022

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

Miransertib

Miransertib capsules administered orally at an initial dose of 15 mg/m\^2 or 25 mg/m\^2 QD and then titrated up to 25 mg/m\^2 or 35 mg/m\^2 QD at the investigator's discretion.

Trial Locations (11)

2298

Hunter Genetics ( Site 0201), Waratah NSW

30342

Children's Hospital of Atlanta ( Site 0107), Atlanta

45229

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

60611

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0101), Chicago

77030

Texas Children's Hospital ( Site 0104), Houston

95123

Universita di Catania ( Site 0088), Catania

98105

Seattle Childrens Hospital ( Site 0103), Seattle

02115

Boston Children's Hospital ( Site 0089), Boston

00165

Ospedale Pediatrico Bambino Gesu ( Site 0087), Rome

00168

Fondazione Policlinico Universitario A. Gemelli ( Site 0052), Roma

08950

Hospital Sant Joan ( Site 0601), Esplugues de Llobregat

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Worldwide Clinical Trials

OTHER

lead

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

INDUSTRY