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)
Running, not enrolling · Phase 2
Conditions studied: PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
In brief
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.
Key facts
- Study ID
- NCT04980872
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 60
- Starts
- 2021-11-02
- Expected to finish
- 2030-02-07
- Last updated by the study team
- 2025-02-07
Who can join
Age: 2 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366)
- For males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for ≥90 days after the last dose of study intervention
- For females, is not pregnant or breastfeeding, and is either not a participant of childbearing potential (POCBP) or is a POCBP and is abstinent or uses a highly effective method of contraception
You may not qualify if…
- Has previously discontinued miransertib due to related SAEs or other intolerance of miransertib
- Has received other investigational agents, if any, that were administered between leaving Study MK-7075-02 or ArQule's CU/EAP and entering this trial
- Is receiving systemic inhibitors of the mechanistic target of rapamycin (mTOR) pathway (eg, sirolimus, everolimus)
- Is receiving immunosuppressive therapies
- Is receiving continuous high dose steroids
Where it is running
- Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107) — Atlanta, Georgia, United States
- Boston Children's Hospital ( Site 0089) — Boston, Massachusetts, United States
- Cincinnati Children's Hospital Medical Center-Hematology ( Site 0102) — Cincinnati, Ohio, United States
- Texas Children's Hospital ( Site 0104) — Houston, Texas, United States
- Seattle Children's Hospital ( Site 0103) — Seattle, Washington, United States
- John Hunter Hospital ( Site 0203) — Newcastle, New South Wales, Australia
- Bundaberg Base Hospital ( Site 0202) — Bundaberg, Queensland, Australia
- Hospital Araújo Jorge ( Site 0801) — Goiânia, Goiás, Brazil
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052) — Rome, Lazio, Italy
- Ospedale Pediatrico Bambino Gesù-Centro Trials ( Site 0087) — Rome, Roma, Italy
- Great Ormond Street Hospital ( Site 0701) — London, London, City of, United Kingdom
Full record on ClinicalTrials.gov
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