[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644902":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":31,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"NanoAlvand","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients receiving temozolomide (Amitzo®, NanoAlvand)",null,[12],"Drug: temozolomide",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","temozolomide","Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.",[9],[20],{"name":21,"affiliation":22,"role":23},"mohadese shahin, Assistant Professor","Iran University of Medical Sciences","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Nassim Anjidani, PharmD","CONTACT","+982143473000","3200","anjidani.n@orchidpharmed.com",[32],{"facility":33,"status":34,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Orchid Pharmed","RECRUITING","Tehran","Iran","IR",{"type":39,"coordinates":40},"Point",[41,42],51.42151,35.69439,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":10,"email":48},"Hamidreza Kafi","+989129232594","Kafi.H@Orchidpharmed.com",{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644902","safety-and-effectiveness-evaluation-of-temozolomide-amitzo-nanoalvand-in-patients-with-grade-iii-and-iv-glioma-tumors-100644902",false,"NCT07675070","Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors","A Phase IV and Observational Study to Evaluate Safety and Effectiveness of Temozolomide (Amitzo, NanoAlvand) Therapy in in Patients With Grade III and IV Glioma Tumors","Inclusion Criteria:\n\n* Patients with newly diagnosed grade III or IV glial tumors, or patients who have experienced disease recurrence or progression after receiving standard treatment and, based on the treating physician's diagnosis, require treatment with temozolomide\n* Patients aged 18-80 years old\n\nExclusion Criteria:\n\n* Patients without a baseline MRI\n* Patients who are unwilling to participate in the study","ALL","18 Years","80 Years",{"count":62,"type":63},100,"ESTIMATED","OBSERVATIONAL","This is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Amitzo® in Iranian patients with grade III and IV glioma tumors. No control group is considered in the study design. The primary objective is to evaluate the incidence of hepatic injury in patients with grade III and IV glioma tumors, treated with Amitzo®.",[67,68,69],"Brain Tumor","Grade III Glioma","Grade IV Glioma",[71,72,73,74,75,76,77],"Brain Neoplasms","Temozolomide","Effectiveness","Safety","Glioma","Amitzo","Adverse Event","2026-06-23",{"date":80,"type":81},"2026-06-30","ACTUAL",{"date":83,"type":81},"2026-03-22",{"date":85,"type":63},"2026-11",{"name":5,"class":6},1]