Study Name
TAS-120-301(FOENIX-CCA3)
ClinicalTrials.gov Identifier (if applicable)
NCT04093362
Clinical Trial Category (check all that apply)
  • First Line Therapy
Study Center
Institution Name
Mayo Clinic
City
Phoenix
State
AZ
Zip Code
85004
Country
United States
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Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com
for a site list
Study Contacts
Principal Investigator
Mitesh Borad, MD
P.I. Phone
(000) 000-0000
P.I. Email
TBD@TBD.com
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Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com
for a site list
Study Coordinator
TBD
Study Coordinator Phone
(000) 000-0000
Study Coordinator Email
TBD@TBD.com
List additional Study Coordinators (include phone number and email)
Please refer to the Clinical Trials. gov listing and contact the Taiho Help Line at clinicaltrialinfo@taihooncology.com
for a site list
OVERVIEW – in layman’s terms (150 words max)
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
216
Study Start Date
08/07/2020
Estimated Completion Date
06/30/2022
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • 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.