A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

简要总结

主要结局

次要结局

• Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator(From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months)
• Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator(From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months)
• Overall Survival (OS)(From the date of first dose of study drug until the date of death, approximately 18 months)
• Safety and tolerability(From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months)
• Seizure Activity(From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months)
• ORR per modified RANO 2.0 assessed by Investigator(From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months)
• Volumetric Tumor Growth Rate (TGR) by BICR(From historical scans through the final scan in the study, approximately 18 months)
• Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator(From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months)
• Time to Next Intervention (TTNI)(From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months)