[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369079":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":15,"locations":7,"responsibleParty":24,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":30,"acronym":7,"eligibilityCriteria":31,"healthyVolunteers":28,"sex":32,"minAge":7,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":33,"phases":7,"briefSummary":34,"conditions":35,"keywords":38,"overallStatus":40,"whyStopped":7,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":45,"locationsCount":7},{"fullName":5,"class":6},"Novartis","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","alpelisib","Patients receive alpelisib",[14],"BYL719",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":7,"email":20},"MAP requests are initiated by a licensed physician. https\u002F\u002F www.novart is.com\u002Fhealthcare-professionals\u002Fmanaged-access-programs","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":22,"role":18,"phone":23,"phoneExt":7,"email":7},"Novartis Pharmaceuticals","+41613241111",{"type":25,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100369079","managed-access-programs-for-byl719-alpelisib-100369079",false,"NCT04085653","Managed Access Programs for BYL719, Alpelisib","Inclusion Criteria:\n\nAn independent request was received from a licensed physician. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n\nThe patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n\nThere is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n\nThe patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n\nProvision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n\nManaged Access provision is allowed per local laws\u002Fregulations.","ALL","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to BYL719, Alpelisib",[36,37],"PIK3CA-Related Overgrowth Spectrum (PROS)","Breast Cancer",[14,11,39],"MAP","AVAILABLE","2026-04-09",{"date":43,"type":44},"2026-04-14","ACTUAL",{"name":22,"class":6}]