Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Burgoyne Adam (ucsd)

Description

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.

Official Title

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

Details

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.

Keywords

Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement, Futibatinib, cholangiocarcinoma, FGFR2, Fusion, Rearrangemen, TAS-120

Eligibility

Locations

  • University of California San Diego UCSD - Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Texas Oncology accepting new patients
    Abilene Texas 79606-5208 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT05727176
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated