An extension study for patients with PROS or Proteus Syndrome currently treated with miransertib
- Conditions
- PIK3CA-related overgrowth spectrum (PROS) and Proteus Syndrome (PS)MedDRA version: 20.0Level: PTClassification code: 10074067Term: Proteus syndrome Class: 100000004850MedDRA version: 21.1Level: PTClassification code: 10081236Term: PIK3CA related overgrowth spectrum Class: 100000004850Therapeutic area: Phenomena and Processes [G] - Genetic Phenomena [G05]
- Registration Number
- CTIS2022-500689-87-00
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 60
Has phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (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), Is male or female, from 2 to 120 years of age, inclusive, 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 woman of childbearing potential (WOCBP) or is a WOCBP and is abstinent or uses a highly effective method of contraception
Has previously discontinued miransertib due to related SAEs or other intolerance, Has received other investigational agents between leaving Study MK-7075-002 or ArQule’s CU/EAP and entering this study, or mTOR pathway inhibitors, immunosuppressive therapies, or continuous high dose steroids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method