Study to assess safety/efficacy of ARQ092 in subjects with PROS and PS
Research type
Research Study
Full title
A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects with PIK3CA-related Overgrowth Spectrum and Proteus Syndrome
IRAS ID
264994
Contact name
Lea Solman
Contact email
Sponsor organisation
ArQule, Inc.
Eudract number
2016-000558-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 12 days
Research summary
Research Summary
The main purpose of this study is to assess the efficacy of ARQ 092 (miransertib) in pediatric and adult patients (2 years of age and older) with PIK3CA-related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS) with documented PIK3CA or AKT1 mutations.
The study drug is ARQ 092 (Miransertib).
The study consists of Part A and Part B. Only Part B will be conducted in the UK and will consist of 4 cohorts: Cohort 1 will enroll subjects with PROS; Cohort 2 will enroll subjects with PS; Cohort 3 will enroll subjects with either PROS or PS who do not meet the eligibility criteria for Cohorts 1 or 2 and Cohort 4 will enroll subjects previously treated with ARQ 092 or currently receiving ARQ 092 under Compassionate Use/Expanded Access.
Up to 65 subjects will be enrolled globally (France, Spain, UK, Italy, Australia, United States, Latin America). Only one site will participate in the UK.
We expect the duration of each patient’s participation to be approximately 48 months.Summery of results
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REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/0047
Date of REC Opinion
16 Jul 2020
REC opinion
Further Information Favourable Opinion