The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor. * Visit the clinic as instructed for checkups and tests. * Keep a diary recording each time a dose of lirafugratinib is taken.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Lirafugratinib is an oral inhibitor of FGFR2
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.
Time frame: 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) assessed by Independent Review Committee per RECIST v1.1.
Time frame: 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.
Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.
Number of patients with dose interruptions.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose reductions.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose discontinuations.
Time frame: Every 28-day cycle until end of treatment, approximately 24 months.
Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.
Time frame: 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.
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
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Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Institut Bergonie
Bordeaux, France
Centre Georges François Leclerc
Dijon, France
...and 8 more locations
Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: 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.
Time frame: 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).
Time frame: Up to approximately 36 months.
Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Up to approximately 36 months.
Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.
Time frame: Up to approximately 36 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)
Time frame: [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)
Time frame: 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)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
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).
It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.
Time frame: Approximately every 4 weeks during treatment, approximately 24 months
Time to deterioration (TTD).
Time frame: Up to approximately 36 months.
FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).
Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.