[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Orbus Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100506821",false,"NCT05879367","Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A\u002FB intact) per WHO 2021 tumor classification.\n* Completed external beam radiation therapy per standard of care.\n* Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.\n* Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.\n* Willing to abstain from intercourse or use acceptable contraceptive methods.\n* If taking corticosteroids, must be on a stable or decreasing dose.\n\nExclusion Criteria:\n\n* Recent history of recurrent or metastatic cancer that could confound response assessments\n* Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).\n* Prior Optune treatment.\n* Active infection or serious intercurrent medical illness.\n* Poorly controlled seizures.\n* Significant cardiac disease within 6 months of enrollment.\n* Poorly controlled diabetes.\n* Use of another investigational agent within 30 days of enrollment.","ALL","18 Years",{"count":18,"type":19},66,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.",[25,26,27,28,29,30,31],"Glioblastoma, IDH-wildtype","Glioblastoma","Glioblastoma Multiforme","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","GBM","Astrocytoma","Astrocytoma, IDH-Mutant","RECRUITING","2025-06-19",{"date":35,"type":36},"2025-06-25","ACTUAL",{"date":38,"type":36},"2023-07-24",{"date":40,"type":19},"2026-06-30",{"name":42,"class":43},"Orbus Therapeutics, Inc.","INDUSTRY",8,""]