Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Status:
Recruiting
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
(FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
The purpose of the study is to evaluate the efficacy and safety of the investigational agent
oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line
treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma
with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or
gemcitabine plus cisplatin.