[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552384":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":25,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"AC Camargo Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Everolimus 5","EXPERIMENTAL","oral everolimus 5 mg\u002Fdaily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.",[13],"Drug: Everolimus 5 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Everolimus 10","ACTIVE_COMPARATOR","oral everolimus 10 mg\u002Fdaily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Everolimus 5 MG","oral everolimus 5 mg\u002Fdaily",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Rachel P Riechelmann, MD","CONTACT","+55112189500","rachel.riechelmann@accamargo.org.br",[33,49],{"facility":5,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","São Paulo","01509010","Brazil","BR",{"type":40,"coordinates":41},"Point",[42,43],-46.63611,-23.5475,{"lat":43,"lon":42},[46],{"name":28,"role":29,"phone":47,"phoneExt":48,"email":31},"+5521895000","2776",{"facility":5,"status":34,"city":35,"state":25,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},[54],{"name":28,"role":29,"phone":25,"phoneExt":25,"email":31},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rachel Riechelmann","Dr","100552384","phase-2-everolimus-5-mg-vs-10-mgdaily-for-patients-with-neuroendocrine-tumors-100552384",false,"NCT06472388","Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Neuroendocrine Tumors","Randomized Phase II Trial of Everolimus 5 mg vs 10 mg\u002FDaily for Patients With Advanced Neuroendocrine Tumors","EVENET","Inclusion Criteria:\n\n* Histological confirmation of well-differentiated Grade 1\u002FGrade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.\n* Metastatic or locally advanced and unresectable disease, measurable by images\n* Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators\n* At least one previous line of systemic treatment (suspended for more than 3 weeks).\n* Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:\n\n  * Hemoglobin \\> 8 g\u002FdL\n  * Neutrophils ≥ 1,500\u002Fmm³\n  * Platelets \\> 90,000\u002Fmm³\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \\[upper limit of normal\\] or ≤ 5 x ULN for patients with liver metastases\n  * Bilirubin ≤ 1.5 x ULN, creatinine \\\u003C 1.5 mg\u002FdL\n\nExclusion Criteria:\n\n* Aggressive disease requiring cytotoxic therapy\n* Severe\u002Funcontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.\n* MiNEN","ALL","16 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Everolimus is approved in many countries to treat patients with advanced\u002Fmetastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg\u002Fday\u002Fweek was sufficient to inhibit cell proliferation by blocking the mTOR pathway.\n\nThis is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral\u002Fdaily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.",[77,78,79,80,81,82,83],"Neuroendocrine Tumors","Progression","Neuroendocrine Tumor Grade 1","Neuroendocrine Tumor Grade 2","Neuroendocrine Tumor of Pancreas","Neuroendocrine Tumor of the Lung","Neuroendocrine Tumor Carcinoid","2024-06-18",{"date":86,"type":87},"2024-06-25","ACTUAL",{"date":89,"type":87},"2024-04-24",{"date":91,"type":71},"2026-12-31",{"name":5,"class":6},2]