Phase 2 Study of Futibatinib 16 mg and 20 mg in Adults With Advanced Cholangiocarcinoma and FGFR2 Gene Fusions or Rearrangements

What this Trial Is About

Researchers are evaluating futibatinib in patients with advanced cholangiocarcinoma CCA that have FGFR2 gene fusions or rearrangements. This open-label, multinational Phase 2 study aims to confirm the clinical benefit of a 20 mg dose and assess the safety and effectiveness of a 16 mg dose in patients who have already undergone prior treatment. The study compares these two doses to better understand their impact on this specific type of cancer. Participants will be randomly assigned to one of two groups receiving futibatinib orally either 16 mg or 20 mg daily in repeated 21-day cycles. Treatment continues until disease progression or other withdrawal criteria occur. Both doses involve taking tablets daily with continuous monitoring throughout the treatment period. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, evaluation of disease progression, overall survival, and quality of life questionnaires. Safety is monitored through adverse event reporting. The main outcome is the objective response rate reviewed independently 12 months after study completion, with additional measures such as duration of response and progression-free survival also evaluated. The study continues until December 2026.

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