[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644902":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":30,"overallOfficials":36,"centralContacts":41,"locations":48,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":11,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"NanoAlvand","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Assessment of the incidence of hepatic injury in patients with grade III and IV glioma tumors, receiving temozolomide (Amitzo®, NanoAlvand)",null,"From enrollment to the end of study at 24 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"Safety of temozolomide (Amitzo®, NanoAlvand) through evaluation of adverse events, based on the treating physician's assessment","* Frequency of causality assessments of adverse events in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand)\n* Severity of adverse events occurring in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand)\n* Incidence of serious adverse events (SAEs) in patients with grade III and IV glioma tumors, treated with temozolomide (Amitzo®, NanoAlvand)",{"measure":18,"description":11,"timeFrame":19},"Response to temozolomide (Amitzo®, NanoAlvand) by evaluating the Overall Response Rate (ORR) in patients, based on the treating physician's assessment or magnetic resonance imaging (MRI) findings","Week 24",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":21,"timePerspective":22,"maskingInfo":11},"COHORT","PROSPECTIVE","This is a phase IV, post-marketing, observational, cohort study to evaluate the safety and effectiveness of Amitzo® in Iranian patients with grade III and IV glioma tumors. To gather the data during the predefined six intervention visits and one follow-up visit of the study, a booklet will be filled by the designated physician. The treatment will be administered during the first 5 days of each 28-day treatment cycle. The primary objective of this study is to evaluate the incidence of hepatic injury in patients with brain tumors treated with Amitzo®. This is a single arm study with a calculated sample size of 100 patients.","A total of 100 Iranian patients diagnosed with grade III or IV gliomas and treated with Amitzo® will be enrolled in the study.",[26],{"label":27,"type":11,"description":11,"interventionNames":28},"Patients receiving temozolomide (Amitzo®, NanoAlvand)",[29],"Drug: temozolomide",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"DRUG","temozolomide","Temozolomide (Amitzo®, NanoAlvand), during the first five days of every 28-day cycle.",[27],[37],{"name":38,"affiliation":39,"role":40},"mohadese shahin, Assistant Professor","Iran University of Medical Sciences","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Nassim Anjidani, PharmD","CONTACT","+982143473000","3200","anjidani.n@orchidpharmed.com",[49],{"facility":50,"status":51,"city":52,"state":11,"zip":11,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Orchid Pharmed","RECRUITING","Tehran","Iran","IR",{"type":56,"coordinates":57},"Point",[58,59],51.42151,35.69439,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":11,"email":65},"Hamidreza Kafi","+989129232594","Kafi.H@Orchidpharmed.com",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":79,"type":80},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®.",[84,85,86],"Brain Tumor","Grade III Glioma","Grade IV Glioma",[88,89,90,91,92,93,94],"Brain Neoplasms","Temozolomide","Effectiveness","Safety","Glioma","Amitzo","Adverse Event","2026-06-23",{"date":97,"type":98},"2026-06-30","ACTUAL",{"date":100,"type":98},"2026-03-22",{"date":102,"type":80},"2026-11",{"name":5,"class":6},1]