TAS-120-301(FOENIX-CCA3)

ClinicalTrials.gov Identifier
NCT04093362
Institution Name
Mayo Clinic
Institution City
Phoenix
Institution State
Arizona
Institution ZIP Code
85004
Institution Country
United States
Additional Institutions
Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com for a site list
Principal Investigator
Mitesh Borad, MD
Additional Principal Investigators
Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com for a site list
Additional Study Coordinators
Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com for a site list
Study Overview
FGFR2(fibroblast growth factor receptor 2) gene rearrangements, have been identified as an early driver of oncogenic events in approximately 15% of CCA patients. Futibatinib (TAS-120),an oral, highly selective, irreversible tyrosine kinase inhibitor (TKI) that inhibits FGFR1-4 isoforms, and have shown evidence of efficacy on CCA.
Enrollment Information
216
Study Start Date
20200807
Study End Date
20230930
Study Purpose
  • Study TAS-120-301 is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements.
Financial Assistance Available
Yes