{"entity":{"id":"nct05303519","kind":"trial","name":"SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","aka":["SIGMA"],"tldr":"A phase 3 trial testing Safusidenib in glioma & glioblastoma, now recruiting.","summary":"SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) is a phase 3 interventional study registered as NCT05303519, led by Nuvation Bio with AnHeart Therapeutics, and recruiting on the registry. Official title: A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma. Planned enrolment is 365 participants (estimated). The study started in 2023-06-05 and primary completion is expected in 2028-12-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05303519","url":"https://clinicaltrials.gov/study/NCT05303519"}],"tags":["ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma"],"sections":[],"technologies":[],"targets":[],"drugs":["safusidenib"],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05303519","phase":"3","setting":"A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","sponsor":"Nuvation Bio","participation":[{"nct":"NCT05303519","source":"https://clinicaltrials.gov/study/NCT05303519","fetchedAt":"2026-10-07T16:53:39.725Z","studySha256":"239f3e00095db52192797b93b47dc241cb2488ff606e695b51dcfa40a84fe765","overallStatus":"RECRUITING","lastUpdatePosted":"2026-08-28","leadSponsor":"Nuvation Bio Inc.","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":365,"enrolmentType":"ESTIMATED","siteCount":61,"recruitingSiteCount":57,"countries":["Australia","China","United States"]}],"started":"2023-06-05","startedType":"actual","enrolled":365,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05303519/","neighbours":{"cancer":[{"id":"idh-mutant-astrocytoma","kind":"cancer","name":"Astrocytoma, IDH-mutant (grades 2 to 4)","route":"/cancers/idh-mutant-astrocytoma/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"drug":[{"id":"safusidenib","kind":"drug","name":"Safusidenib","route":"/drugs/safusidenib/"}],"company":[{"id":"nuvation-bio","kind":"company","name":"Nuvation Bio","route":"/companies/nuvation-bio/"}]}}