Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Taiho Oncology, Inc.
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.
Description
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. Eligible patients will be randomized on a 1:1 basis to the following study arms: * Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle. * Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle. Patients may continue to…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma. 2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement 3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA 4. Documentation of radiographic disease progression on the most recent prior therapy 5. Measurable disease 6. performance status 0 or 1 7. Adequate organ function Exclusion Criteria: 1. History or current evidence of calcium and phosphate homeostasis disorder 2. Current evi…
Interventions
- DrugTAS-120
TAS-120 is an oral FGFR inhibitor
Locations (65)
- University of California San Diego UCSD - Moores Cancer CenterLa Jolla, California
- Tampa General Hospital Cancer InstituteTampa, Florida
- Henry Ford Health SystemDetroit, Michigan
- Gabrail Cancer Center ResearchCanton, Ohio
- Texas OncologyAbilene, Texas
- The Liver Institute at Methodist Dallas Medical CenterDallas, Texas