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Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
120 patients around the world
Available in United States, Argentina, Brazil
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 receive continuous futibatinib until documentation of
progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met,
whichever comes first.
Taiho Oncology, Inc.
7Research sites
120Patients around the world
This study is for people with
Bile Duct Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangementReceived at least one prior systemic gemcitabine and platinum-based regimen for CCADocumentation of radiographic disease progression on the most recent prior therapyMeasurable diseaseperformance status 0 or 1Adequate organ function
- History or current evidence of calcium and phosphate homeostasis disorderCurrent evidence of clinically significant retinal disorderTreatment with any of the following within the specified time frame prior to the first dose of futibatinib:A serious illness or medical condition(s) including (but not limited to) the following:Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.Pregnant or lactating female.Known hypersensitivity or severe reaction to futibatinib or its excipients.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Sanatorio de la Mujer - Rosario
Recruiting
Instituto do Cancer do Estado de Sao Paulo
Instituto de Oncologia do Paraná - IOP
Hospital Erasto Gaertner
Hospital De Base de São José do Rio Preto - CIP São José
StudyFOENIX-CCA4
SponsorTaiho Oncology, Inc.
Conditions
Bile Duct Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05727176
