Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (NCT05727176) | Clinical Trial Compass
RecruitingPhase 2
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
United States120 participantsStarted 2023-07-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Measurable disease
✓. performance status 0 or 1
✓. Adequate organ function
Exclusion criteria
✕. History or current evidence of calcium and phosphate homeostasis disorder
✕. Current evidence of clinically significant retinal disorder
✕. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
✕. 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
. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
✕. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.