Clinical Trial

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Study acronym: FOENIX-CCA4
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 27 amendments
This ClinicalTrials.gov record has been amended 27 times since 2023-02-03; most recent amendment 2026-07-27.
Status change: Not Yet Recruiting → Recruiting 2023-06-13
Trial Details
NCT Number NCT05727176
Lead Sponsor Taiho Oncology, Inc.
Conditions Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
Enrollment 120 participants
Start Date 2023-07-05
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-28