[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06506955":3,"trial-entities:NCT06506955":138,"trial-summary:NCT06506955":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":50,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":67,"locations":70,"central_contacts":134,"overall_officials":135,"references":136,"see_also_links":137},"NCT06506955","TAS120-404","Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.","An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study","ACTIVE_NOT_RECRUITING","2027-04-30","2026-07","2026-07-28","2024-10-01","Taiho Oncology, Inc.","INDUSTRY",false,"This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.","TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.\n\nPatients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.",[19],"Advanced\u002FMetastatic Cancer",[21,22,23,24,25,26],"Futibatinib","TAS-120","FGFR","Cholangiocarcinoma","Breast cance","Urothelial Carcinom","INTERVENTIONAL","TREATMENT",[30,31],"PHASE2","PHASE3",{"count":33,"type":34},15,"ESTIMATED",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DRUG","futibatinib","TAS-120 futibatinib monotherapy",[41],"TAS-120 (futibatinib) monotherapy",[22],{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":48},"futibatinib, fulvestrant","TAS-120 futibatinib combination therapy with fulvestrant",[47],"TAS-120 (futibatinib) combination therapy with fulvestrant",[49],"TAS-120 + fulvestrant",[51],{"measure":52,"description":53,"timeFrame":54},"Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.","To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk","through study completion, an average of 5 years",[],"ALL","18 Years",null,{"inclusion":60,"exclusion":65,"raw_text":66},[61,62,63,64],"Provide written informed consent.","Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.","Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.","Ability to take medications orally (PO) (feeding tube is not permitted).",[],"Inclusion Criteria:\n\n* Provide written informed consent.\n* Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.\n* Ability to take medications orally (PO) (feeding tube is not permitted).\n\nExclusion Criteria:\n\n• Has met any discontinuation criteria within the antecedent futibatinib study.",[68,69],"ADULT","OLDER_ADULT",[71,80,88,95,103,111,118,126,130],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"University of California, San Francisco (UCSF)","San Francisco","California","94143","United States",{"lat":78,"lon":79},37.77493,-122.41942,{"facility":81,"city":82,"zip":83,"country":84,"geoPoint":85},"Institut Paoli-Calmettes","Marseille","13009","France",{"lat":86,"lon":87},43.29695,5.38107,{"facility":89,"city":90,"zip":91,"country":84,"geoPoint":92},"Institut De Cancerologie Strasbourg","Strasbourg","67033",{"lat":93,"lon":94},48.58392,7.74553,{"facility":96,"city":97,"zip":98,"country":99,"geoPoint":100},"Severance Hospital","Seoul","3722","South Korea",{"lat":101,"lon":102},37.566,126.9784,{"facility":104,"city":105,"zip":106,"country":107,"geoPoint":108},"Hospital Universitari, Vall d'Hebron","Barcelona","8035","Spain",{"lat":109,"lon":110},41.38879,2.15899,{"facility":112,"city":113,"zip":114,"country":107,"geoPoint":115},"Centro Integral Oncologico","Madrid","28050",{"lat":116,"lon":117},40.4165,-3.70256,{"facility":119,"city":120,"zip":121,"country":122,"geoPoint":123},"Royal Marsden NHS Foundation Trust","London","SW3 6JJ","United Kingdom",{"lat":124,"lon":125},51.50853,-0.12574,{"facility":127,"city":120,"zip":128,"country":122,"geoPoint":129},"Sarah Cannon Research Institute UK","W1G 6AD",{"lat":124,"lon":125},{"facility":131,"city":120,"zip":132,"country":122,"geoPoint":133},"University College London Hospitals NHS Foundation Trust","W1T 7HA",{"lat":124,"lon":125},[],[],[],[],{"nct_id":4,"conditions":139,"biomarkers":143},[140,24,141,142],"Breast Carcinoma","Solid Neoplasm","Urothelial Carcinoma",[144],"Fibroblast Growth Factor Receptor Family",{"nct_id":4,"found":15,"summary":58,"prompt_version":58}]