Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed, locally advanced, 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
Disqualifiers
History or current evidence of calcium and phosphate homeostasis disorder
Current evidence of clinically significant retinal disorder
Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
Trial design
Treatments tested in this trial
- TAS-120
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov