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803-0226","Sarah.price@cchmc.org",{"facility":360,"status":105,"city":361,"state":347,"zip":362,"country":109,"countryCode":110,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Cleveland Clinic Children's","Cleveland","44195",{"type":112,"coordinates":364},[365,366],-81.69541,41.4995,{"lat":366,"lon":365},[369],{"name":370,"role":99,"phone":371,"phoneExt":11,"email":372},"Ana Beatriz Ferreira Alves","216-636-1926","ferreia2@ccf.org",{"facility":374,"status":105,"city":375,"state":376,"zip":377,"country":109,"countryCode":110,"cosmosGeoPoint":378,"geoPoint":382,"contacts":383},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":112,"coordinates":379},[380,381],-75.16362,39.95238,{"lat":381,"lon":380},[384],{"name":385,"role":99,"phone":386,"phoneExt":387,"email":388},"Melissa Casey","267-426-9188","Option 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Eng","206-884-4626","Whitney.Eng@seattlechildrens.org",{"facility":420,"status":105,"city":421,"state":422,"zip":423,"country":109,"countryCode":110,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"University of Wisconsin, Madison","Madison","Wisconsin","53715",{"type":112,"coordinates":425},[426,427],-89.40123,43.07305,{"lat":427,"lon":426},[430],{"name":431,"role":99,"phone":11,"phoneExt":11,"email":432},"Department of Dermatology","info@clinicaltrials.wisc.edu",{"facility":434,"status":105,"city":435,"state":436,"zip":437,"country":438,"countryCode":439,"cosmosGeoPoint":440,"geoPoint":444,"contacts":445},"Sydney Children's Hospital, Randwick","Randwick","New South Wales","2031","Australia","AU",{"type":112,"coordinates":441},[442,443],151.24895,-33.91439,{"lat":443,"lon":442},[446],{"name":447,"role":99,"phone":448,"phoneExt":11,"email":449},"Sandra 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Gemelli","Roma","00168",{"type":112,"coordinates":591},[592,593],11.10642,44.99364,{"lat":593,"lon":592},[596],{"name":597,"role":99,"phone":598,"phoneExt":11,"email":599},"Dr. Chiara Leoni","+39 06 3015 4584","chiara.leoni@policlinicogemelli.it",{"facility":601,"status":105,"city":588,"state":11,"zip":11,"country":574,"countryCode":575,"cosmosGeoPoint":602,"geoPoint":604,"contacts":605},"Ospedale Pediatrico Bambino Gesù IRCCS",{"type":112,"coordinates":603},[592,593],{"lat":593,"lon":592},[606],{"name":607,"role":99,"phone":608,"phoneExt":11,"email":609},"Andrea Diociaiuti","+390668592509","andrea.diociaiuti@opbg.net",{"facility":611,"status":105,"city":612,"state":11,"zip":11,"country":574,"countryCode":575,"cosmosGeoPoint":613,"geoPoint":617,"contacts":618},"A.O.U Città della Salute e della Scienza di Torino","Torino",{"type":112,"coordinates":614},[615,616],11.99138,44.88856,{"lat":616,"lon":615},[619],{"name":620,"role":99,"phone":621,"phoneExt":11,"email":622},"Dr. Alessandro Mussa","+390113135689","alessandro.mussa@unito.it",{"facility":624,"status":105,"city":625,"state":11,"zip":11,"country":626,"countryCode":627,"cosmosGeoPoint":628,"geoPoint":632,"contacts":633},"Hospital Universitario A Coruña","A Coruña","Spain","ES",{"type":112,"coordinates":629},[630,631],-8.396,43.37135,{"lat":631,"lon":630},[634],{"name":635,"role":99,"phone":636,"phoneExt":11,"email":637},"Servicio Cirugía Pediátrica CHUAC","34981178128","cirugia.infantil.chuac@sergas.es",{"facility":639,"status":105,"city":640,"state":11,"zip":11,"country":626,"countryCode":627,"cosmosGeoPoint":641,"geoPoint":645,"contacts":646},"Hospital Sant Joan de Deu","Barcelona",{"type":112,"coordinates":642},[643,644],2.15899,41.38879,{"lat":644,"lon":643},[647,650],{"name":648,"role":99,"phone":11,"phoneExt":11,"email":649},"Eulalia Baslega Torres","eulalia.baselga@sjd.es",{"name":651,"role":99,"phone":11,"phoneExt":11,"email":652},"Raquel Masip","raquel.masip@sjd.es",{"facility":654,"status":105,"city":655,"state":11,"zip":11,"country":626,"countryCode":627,"cosmosGeoPoint":656,"geoPoint":660,"contacts":661},"Hospital Universitario La Paz","Madrid",{"type":112,"coordinates":657},[658,659],-3.70256,40.4165,{"lat":659,"lon":658},[662],{"name":663,"role":99,"phone":664,"phoneExt":11,"email":665},"Juan Carlos López Gutiérrez","+34917277019","juanc.lopez@salud.madrid.org",{"facility":667,"status":105,"city":668,"state":11,"zip":669,"country":670,"countryCode":671,"cosmosGeoPoint":672,"geoPoint":676,"contacts":677},"Chelsea and Westminster Hospital","London","SW10 9NH","United Kingdom","UK",{"type":112,"coordinates":673},[674,675],-0.12574,51.50853,{"lat":675,"lon":674},[678],{"name":679,"role":99,"phone":680,"phoneExt":11,"email":681},"Rhian Bull","+44 0203 3155295","Rhian.Bull@nhs.net",{"facility":683,"status":105,"city":668,"state":11,"zip":11,"country":670,"countryCode":671,"cosmosGeoPoint":684,"geoPoint":686,"contacts":687},"Great Ormond Street Hospital for Children",{"type":112,"coordinates":685},[674,675],{"lat":675,"lon":674},[688],{"name":689,"role":99,"phone":690,"phoneExt":11,"email":691},"Maanasa Polubothu","+4402074059200","maanasa.polubothu@gosh.nhs.uk",{"type":693,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100576793","phase-2-a-phase-2-study-of-mutant-selective-pi3k-inhibitor-rly-2608-in-adults-and-children-with-pik3ca-related-overgrowth-spectrum-and-malformations-driven-by-pik3ca-mutation-the-reinspire-study-100576793",false,"NCT06789913","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)","A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation","Key Inclusion Criteria:\n\n* The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.\n* One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and\u002For cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.\n* Lansky (\\\u003C16 yo) or Karnofsky (≥16 yo) performance status of ≥50.\n* Agree to provide archived lesional fluid and\u002For tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to RLY-2608.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Clinically significant, uncontrolled cardiovascular disease\n* Received disease-directed therapy prior to the first dose of study drug:\n\n  1. Systemic therapy or antibody within 5 half-lives of the therapy.\n  2. Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.","ALL","2 Years",{"count":704,"type":705},277,"ESTIMATED","INTERVENTIONAL",[708],"PHASE2","This is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.",[711,712,713,714,715,716,717,718],"PIK3CA-Related Overgrowth Spectrum (PROS)","Lymphatic Malformations","Vascular Malformations","PIK3CA Mutation","CLOVES Syndrome","Klippel Trenaunay Syndrome","Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)","Vascular Anomalies","2026-08-21",{"date":721,"type":722},"2026-08-25","ACTUAL",{"date":724,"type":722},"2025-06-13",{"date":726,"type":705},"2031-10",{"name":5,"class":6},40]