Study

Overview

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

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.

Study Type:

Interventional

Study Phase:

Phase 2

Estimated Enrollment:

60

Study Start Date:

November 2021

Estimated Study Completion Date:

September 2026

Estimated Primary Completion Date:

September 2026

Eligibility

Ages Eligible for Study:

2 years to 120 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

Has PROS or PS and is currently being actively treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule’s Compassionate Use and Extended Access Program (CU/EAP, NCT03317366)

Exclusion Criteria:

Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib
Received other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule’s CU/EAP and entering this trial
Receives inhibitors of the mechanistic target of rapamycin (mTOR) pathway (eg, sirolimus, everolimus)
Receives immunosuppressive therapies
Receives continuous high dose steroids

Study Detail

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)

Overview

Eligibility

CRITERIA

Locations

Results

Plain Language Summaries