Brief Summary
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.
Intervention / Treatment
- Drug: TAS-120
Inclusion Criteria:
- Histologically or cytologically confirmed, locally advancedat a late stage, far along, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
- Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
- Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
- Documentation of radiographic disease progression on the most recent prior therapy
- Measurable disease
- performance status 0 or 1
- Adequate organ function.