TAS-120-301(FOENIX-CCA3)

ClinicalTrials.gov Identifier

NCT04093362

Institution Name

Mayo Clinic

Full Institution Address

Phoenix
Arizona
85004
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