[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556713":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":65,"centralContacts":69,"locations":79,"responsibleParty":172,"collaborators":174,"id":178,"slug":74,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":74,"eligibilityCriteria":183,"healthyVolunteers":179,"sex":184,"minAge":74,"maxAge":185,"enrollmentInfo":186,"targetDuration":74,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":81,"whyStopped":74,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Entrectinib therapy, Cohort 1 and Cohort 2","EXPERIMENTAL","Cohort 1: Patients who are younger than 3 years of age diagnosed with NTRK1\u002F2\u002F3- or ROS1-fused high-grade glioma (HGG) will receive therapy as outline in Detailed Description.\n\nCohort 2: Patients who are younger than 3 years of age diagnosed with NTRK1\u002F2\u002F3- or ROS1-fused CNS tumors other than HGG will receive therapy as outline in Detailed Description.",[13,14,15,16,17,18,19],"Drug: Entrectinib","Drug: Cyclophosphamide","Drug: Etoposide","Drug: Carboplatin","Biological: G-CSF","Biological: Pegfilgrastim","Procedure: Surgery",[21,28,34,40,45,52,58],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Entrectinib","Given orally (PO) or enterally",[9],[27],"Rozlytrek",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Cyclophosphamide","Given intravenous (IV)",[9],[33],"Cytoxan®",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Etoposide","Given IV",[9],[39],"VP-16",{"type":22,"name":41,"description":36,"armGroupLabels":42,"otherNames":43},"Carboplatin",[9],[44],"Paraplatin®",{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"BIOLOGICAL","G-CSF","Given subcutaneous (SQ) or IV",[9],[51],"Filgrastim",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Pegfilgrastim","Given SQ as part of recommended Bridging Therapy instead of G-CSF.",[9],[57],"Neulasta",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"PROCEDURE","Surgery","A gross total resection or significant debulking may become possible if a response to entrectinib is seen.",[9],[64],"Surgical resection",[66],{"name":67,"affiliation":5,"role":68},"Daniel Moreira, MD, MEd","PRINCIPAL_INVESTIGATOR",[70,76],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},"Tabatha E. Doyle, RN","CONTACT","901-595-2544",null,"tabatha.doyle@stjude.org",{"name":67,"role":72,"phone":77,"phoneExt":74,"email":78},"901-585-1911","daniel.moreira@stjude.org",[80,97,114,128,140,157],{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"RECRUITING","Memphis","Tennessee","38105","United States",{"type":87,"coordinates":88},"Point",[89,90],-90.04898,35.14953,{"lat":90,"lon":89},[93,94,96],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},{"name":74,"role":72,"phone":74,"phoneExt":74,"email":95},"GLOBOTRK@stjude.com",{"name":67,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":98,"status":81,"city":99,"state":100,"zip":101,"country":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Hospital de Câncer de Barretos","Barretos","São Paulo","14784400","Brazil",{"type":87,"coordinates":104},[105,106],-48.56778,-20.55722,{"lat":106,"lon":105},[109,113],{"name":110,"role":72,"phone":111,"phoneExt":74,"email":112},"Thais J. Vampre, MD","17 3321-6647","thaisjunq79@gmail.com",{"name":110,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":115,"status":81,"city":100,"state":74,"zip":116,"country":102,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)","04039-001",{"type":87,"coordinates":118},[119,120],-46.63611,-23.5475,{"lat":120,"lon":119},[123,127],{"name":124,"role":72,"phone":125,"phoneExt":74,"email":126},"Andrea M. Cappellano, MD","+55 11 5080-8400","andreacappellano@graacc.org.br",{"name":124,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":129,"status":81,"city":100,"state":74,"zip":130,"country":102,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Hospital Santa Marcelina","08270-070",{"type":87,"coordinates":132},[119,120],{"lat":120,"lon":119},[135,139],{"name":136,"role":72,"phone":137,"phoneExt":74,"email":138},"Sidnei Epelman, MD","+55 11 2522-2472","epelman@inctrbrasil.org",{"name":136,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":141,"status":81,"city":142,"state":74,"zip":143,"country":144,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"King Hussein Cancer Center","Amman","11941","Jordan",{"type":87,"coordinates":146},[147,148],35.94503,31.95522,{"lat":148,"lon":147},[151,156],{"name":152,"role":72,"phone":153,"phoneExt":154,"email":155},"Nisreen Amayiri, MD","(962 6) 5300460","6376","namayiri@khcc.jo",{"name":152,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":158,"status":81,"city":159,"state":74,"zip":74,"country":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Instituto Nacional de Enfermedades Neoplásicas","Lima","Peru",{"type":87,"coordinates":162},[163,164],-77.02824,-12.04318,{"lat":164,"lon":163},[167,171],{"name":168,"role":72,"phone":169,"phoneExt":74,"email":170},"Rosdali Coronado, MD","+51 991765893","rosdali.diaz.c@upch.pe",{"name":168,"role":68,"phone":74,"phoneExt":74,"email":74},{"type":173,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR",[175],{"name":176,"class":177},"Hoffmann-La Roche","INDUSTRY","100556713",false,"NCT06528691","Entrectinib as a Single Agent in Upfront Therapy for Children \u003C3 Years of Age With NTRK1\u002F2\u002F3 or ROS1-FUSED CNS Tumors","PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children \u003C3 Years of Age With NTRK1\u002F2\u002F3 or ROS1-FUSED CNS Tumors (GLOBOTRK)","Inclusion Criteria: Screening Phase\n\n* Age from birth to age \\\u003C3 years at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* Participant with presumed newly diagnosed tumor in the supratentorial compartment\n* Patient must have measurable disease based on RAPNO criteria\n* ≤84 days since surgery (resection or biopsy)\n* Available tumor tissue for central review\n* Parent\u002Fguardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines\n\nExclusion Criteria: Screening Phase\n\n* Previous exposure to cytotoxic chemotherapy or radiotherapy\n\nInclusion Criteria: COHORT 1\n\n* Patients must be \\\u003C3 years of age at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* High-grade glioma (World Health Organization \\[WHO\\] grade III or IV) harboring NTRK1\u002F2\u002F3 or ROS1 gene fusions as determined by central pathology review\n* Patients must have measurable disease as defined by RAPNO criteria\n* Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation\n* ≤28 days since study screening\n* Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks\n* Neurologic deficits must have been stable for at least 7 days prior to study enrollment\n* Hemoglobin ≥ 8 g\u002FdL (without transfusion or erythropoietin use within 7 days prior to enrollment)\n* Platelet count ≥ 75,000\u002FµL (without transfusion within 7-day period prior to enrollment)\n* Absolute neutrophil count \\>1,000\u002FµL\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x the upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 x ULN\n* Adequate renal function as defined by the following age-based serum creatinine concentrations:\n\n  * 0 to \\\u003C1 year: 0.5 mg\u002FdL\n  * 1 to \\\u003C2 years: 0.6 mg\u002FdL\n  * 2 to 3 years: 0.8 mg\u002FdL\n* Adequate cardiac function as defined by electrocardiogram (ECG) with Fridericia's corrected QT interval (QTc) ≤ 450 msec and echocardiogram left ventricular ejection fraction (LVEF) \\>50%\n* Screening and enrollment consents signed\n* Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures\n\nInclusion Criteria: COHORT 2\n\n* Patients must be \\\u003C3 years of age at the time of diagnosis (date of surgical resection\u002Fbiopsy)\n* CNS tumor other than HGG harboring NTRK1\u002F2\u002F3 or ROS1 gene fusions as determined by central pathology review\n* Patients must have measurable disease as defined by RAPNO criteria\n* Patients are eligible at the time of diagnosis, prior to any exposure to chemotherapy, targeted therapy, immunotherapy, cellular therapy or radiation\n* ≤28 days since study screening\n* Lansky score ≥50% and a minimum life expectancy of ≥ 12 weeks\n* Neurologic deficits must have been stable for at least 7 days prior to study enrollment.\n* Hemoglobin ≥ 8 g\u002FdL (without transfusion or erythropoietin use within 7 days prior to enrollment)\n* Platelet count ≥ 75,000\u002FµL (without transfusion within 7-day period prior to enrollment);\n* Absolute neutrophil count \\>1,000\u002FµL.\n* ALT and ALT ≤2.5x the upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 x ULN\n* Adequate renal function as defined by the following age-based serum creatinine concentrations:\n\n  * 0 to \\\u003C1 year: 0.5 mg\u002FdL\n  * 1 to \\\u003C2 years: 0.6 mg\u002FdL\n  * 2 to 3 years: 0.8 mg\u002FdL\n* Adequate cardiac function as defined by ECG with QTc ≤ 450 msec and echocardiogram LVEF \\>50%\n* Screening and enrollment consents signed\n* Willingness and ability to comply with treatment plan, scheduled visits, laboratory tests and other study procedures\n\nExclusion Criteria: COHORT 1 AND 2\n\n* Clinically significant medical disorder that could compromise the ability to tolerate study therapy or would interfere with the study procedures or results history\n* History of recent (3 months) symptomatic congestive heart failure\n* Known active, uncontrolled infection (bacterial, fungal, or viral)\n* Receiving enzyme inducing antiepileptic drugs (EIAEDs)\n* Any prior cancer therapy including chemotherapy (excluding Bridging Chemotherapy Cycle), targeted therapy, immunotherapy, cellular therapy, or radiation\n* Receiving another investigational agent concurrently\n* Surgery within 2 weeks prior to treatment enrollment\n* Patients with known hypersensitivity to excipients of the investigational medicinal product\n* Active gastrointestinal disease or malabsorption disorder (e.g. Crohn's disease, ulcerative colitis, short-gut syndrome) that would impair drug absorption\n* Inability to take medication enterally","ALL","3 Years",{"count":187,"type":188},52,"ESTIMATED","INTERVENTIONAL",[191],"PHASE2","This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1\u002F2\u002F3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.",[194,195],"High Grade Glioma","CNS Tumor",[197,198,199,200,201,202],"CNS Tumors","High Grade Glioma with NTRK1\u002F2\u002F3 gene fusion","High Grade Glioma with ROS1 gene fusion","CNS tumor other than HGG harboring NTRK1\u002F2\u002F3 gene fusion","CNS tumor other than HGG harboring ROS1 gene fusion","Children","2026-05-12",{"date":205,"type":206},"2026-05-13","ACTUAL",{"date":208,"type":206},"2026-05-01",{"date":210,"type":188},"2032-11",{"name":5,"class":6},6]