A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
- Confirmed diagnosis of HCC by histological examination or by non-invasive criteria according to European Association for the Study of the Liver (EASL) or American Association for the Study of Liver Disease (AASLD) guidelines (Part 1, 2 and 3).
- For Part 1 and 2, the patient has unresectable disease and has been previously treated with sorafenib, has declined treatment with sorafenib, or does not have access to sorafenib.
- For Part 3, the patient has not received prior treatment with a TKI.
- Child-Pugh class A with no clinically apparent ascites
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- For Part 1, willing to provide archived tumor tissue (if available) and willing to undergo pre- and on-treatment tumor biopsy (if considered safe and medically feasible by the treating investigator)
- For Part 2 and 3, all patients must have an FGF19 IHC result available. Only FGF19 IHC+ HCC patients will be eligible for Part 3.
- Central nervous system metastases
- Platelet count <75,000/mL
- Absolute neutrophil count <1000/mL
- Hemoglobin <8 g/dL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal (ULN)
- Total bilirubin >2.5 mg/dL
- International normalized ratio (INR) >2.3 or prothrombin time (PT) >6 seconds above control
- Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min
Salt Lake City
Trial Phase Phase I
Trial Type Treatment
Blueprint Medicines Corporation
- Primary ID BLU-554-1101
- Secondary IDs NCI-2015-01683, 2015-001662-26
- Clinicaltrials.gov ID NCT02508467