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Trial Summary

This 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

Acronym:

FOENIX / TAS120

ACTRN/NCT /ethics:

NCT04093362

Scientific title:

A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3

Sponsor / Cooperative group:

Taiho Oncology, Inc.

Trial & Patient Characteristics

Cancer TypeOther
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream Advanced Cholangeiocarcinoma FGFR2 gene rearrangements
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2020-03-01
Anticipated End Date2025-04-01

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorHannah Adelson
EmailHannah.adelson@sa.gov.au
Phone08 8206 4835
Principal InvestigatorProfessor Chris Karapetis
Recruitment StatusRecruiting