[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556713":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":65,"centralContacts":69,"locations":79,"responsibleParty":176,"collaborators":178,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":74,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":74,"maxAge":190,"enrollmentInfo":191,"targetDuration":74,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":81,"whyStopped":74,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"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",[80,98,116,130,142,160],{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-90.04898,35.14953,{"lat":91,"lon":90},[94,95,97],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},{"name":74,"role":72,"phone":74,"phoneExt":74,"email":96},"GLOBOTRK@stjude.com",{"name":67,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":99,"status":81,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Hospital de Câncer de Barretos","Barretos","São Paulo","14784400","Brazil","BR",{"type":88,"coordinates":106},[107,108],-48.56778,-20.55722,{"lat":108,"lon":107},[111,115],{"name":112,"role":72,"phone":113,"phoneExt":74,"email":114},"Thais J. Vampre, MD","17 3321-6647","thaisjunq79@gmail.com",{"name":112,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":117,"status":81,"city":101,"state":74,"zip":118,"country":103,"countryCode":104,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)","04039-001",{"type":88,"coordinates":120},[121,122],-46.63611,-23.5475,{"lat":122,"lon":121},[125,129],{"name":126,"role":72,"phone":127,"phoneExt":74,"email":128},"Andrea M. Cappellano, MD","+55 11 5080-8400","andreacappellano@graacc.org.br",{"name":126,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":131,"status":81,"city":101,"state":74,"zip":132,"country":103,"countryCode":104,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"Hospital Santa Marcelina","08270-070",{"type":88,"coordinates":134},[121,122],{"lat":122,"lon":121},[137,141],{"name":138,"role":72,"phone":139,"phoneExt":74,"email":140},"Sidnei Epelman, MD","+55 11 2522-2472","epelman@inctrbrasil.org",{"name":138,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":143,"status":81,"city":144,"state":74,"zip":145,"country":146,"countryCode":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"King Hussein Cancer Center","Amman","11941","Jordan","JO",{"type":88,"coordinates":149},[150,151],35.94503,31.95522,{"lat":151,"lon":150},[154,159],{"name":155,"role":72,"phone":156,"phoneExt":157,"email":158},"Nisreen Amayiri, MD","(962 6) 5300460","6376","namayiri@khcc.jo",{"name":155,"role":68,"phone":74,"phoneExt":74,"email":74},{"facility":161,"status":81,"city":162,"state":74,"zip":74,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Instituto Nacional de Enfermedades Neoplásicas","Lima","Peru","PE",{"type":88,"coordinates":166},[167,168],-77.02824,-12.04318,{"lat":168,"lon":167},[171,175],{"name":172,"role":72,"phone":173,"phoneExt":74,"email":174},"Rosdali Coronado, MD","+51 991765893","rosdali.diaz.c@upch.pe",{"name":172,"role":68,"phone":74,"phoneExt":74,"email":74},{"type":177,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR",[179],{"name":180,"class":181},"Hoffmann-La Roche","INDUSTRY","100556713","phase-2-entrectinib-as-a-single-agent-in-upfront-therapy-for-children-3-years-of-age-with-ntrk123-or-ros1-fused-cns-tumors-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":192,"type":193},52,"ESTIMATED","INTERVENTIONAL",[196],"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.",[199,200],"High Grade Glioma","CNS Tumor",[202,203,204,205,206,207],"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":210,"type":211},"2026-05-13","ACTUAL",{"date":213,"type":211},"2026-05-01",{"date":215,"type":193},"2032-11",{"name":5,"class":6},6]