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)

• Status: Recruiting
• Trial end date: 2025-08-29
• Target enrollment: 0
• Participant gender: All

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) and Proteus Syndrome (PS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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