[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594818":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":32,"responsibleParty":48,"collaborators":21,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":21,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":21,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":21,"overallStatus":72,"whyStopped":21,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FCN-159","EXPERIMENTAL","Study Drug: FCN-159 Dosing Regimen: FCN-159 to be administered once daily until disease progression or study completion, whichever occurs first",[13],"Drug: Luvometinib Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Luvometinib Tablets","5mg\u002Fm² (Maximum dose does not exceed 8mg, the recommended oral dose for adults), orally, once daily, until disease progression or study completion, whichever occurs first",[9],[9],null,[23,28],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Xiaojie Hu","CONTACT","+86 13701997136","hxjie2002@hotmail.com",{"name":29,"role":25,"phone":30,"phoneExt":21,"email":31},"Xiaoxi Lin","+86 18017681268","linxiaoxi@126.com",[33],{"facility":34,"status":21,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Shanghai Ninth People's Hospital","Shanghai","Shanghai Municipality","200011","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},{"type":49,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100594818","phase-1-follow-up-study-to-evaluate-the-safety-and-efficacy-of-fcn-159-in-pediatric-participants-with-neurofibromatosis-type-1-100594818",false,"NCT07024394","Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1","A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Ruvometinib Tablets (FCN-159 Tablets) in Pediatric Participants With Neurofibromatosis Type 1","Inclusion Criteria:\n\nPatients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form.\n\nExclusion Criteria:\n\nAny clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.\n\nPatients unable to comply with visit-related requirements.","ALL","2 Years","20 Years",{"count":61,"type":62},65,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1\u002F2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.",[69,70,71],"Neurofibromatosis 1","Plexiform Neurofibroma","NF1","NOT_YET_RECRUITING","2025-06-09",{"date":75,"type":76},"2025-06-17","ACTUAL",{"date":78,"type":62},"2025-06-12",{"date":80,"type":62},"2029-09-23",{"name":5,"class":6},1]