A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

简要总结

主要结局

次要结局

• Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.)
• Number of patients with adverse events and serious adverse events.(Every cycle (4-week cycles) until study discontinuation, approximately 24 months.)
• Number of patients with dose interruptions.(Every 28-day cycle until end of treatment, approximately 24 months.)
• Number of patients with dose reductions.(Every 28-day cycle until end of treatment, approximately 24 months.)
• Number of patients with dose discontinuations.(Every 28-day cycle until end of treatment, approximately 24 months.)
• Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.)
• Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months)
• Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.)
• Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months)
• Overall survival (OS).(Up to approximately 36 months.)
• Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.(Up to approximately 36 months.)
• Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.(Up to approximately 36 months)
• Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)([Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)])
• Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)(Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles))
• Pharmacokinetic parameters including half-life (t1/2)(Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles))
• Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).(Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.)
• Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).(Approximately every 4 weeks during treatment, approximately 24 months)
• Time to deterioration (TTD).(Up to approximately 36 months.)
• FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.(Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.)
• Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).(Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.)
• Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)(Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months)
• Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)(Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months)