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Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement — FOENIX-CCA4  

Advanced Cholangiocarcinoma Clinical Trial

Official title:
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05727176
Study type Interventional
Source Taiho Oncology, Inc.
Contact Taiho Oncology, INC
Phone 609-250-7336
Email clinicaltrialinfo@taihooncology.com
Status Recruiting
Phase Phase 2
Start date May 12, 2023
Completion date June 2026
View Details
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