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Active (not recruiting) Phase 2 NCT04980872

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)

Phase 2 – studying effectiveness and dosage
Conditions: PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations 5
Australia (1)
John Hunter Hospital ( Site 0203)
Newcastle , New South Wales
Brazil (1)
Hospital Araújo Jorge ( Site 0801)
Goiânia , Goiás
Italy (1)
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0052)
Rome , Lazio
United Kingdom (1)
Great Ormond Street Hospital ( Site 0701)
London , London, City of
United States (1)
Children's Healthcare of Atlanta - Egleston Hospital ( Site 0107)
Atlanta , Georgia
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
2 Years
Maximum age
120 Years
Healthy volunteers
No
Start date
02.11.2021
Completion date
07.02.2030
Registry ID
NCT04980872
Source
anzctr
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