Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
Documentation of radiographic disease progression on the most recent prior therapy
Disqualifiers
History or current evidence of calcium and phosphate homeostasis disorder
Current evidence of clinically significant retinal disorder
Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
Trial design
Design model
Parallel
Treatments tested in this trial
TAS-120
DrugTAS-120 is an oral FGFR inhibitor
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Treatment Arm AExperimental treatment 1 intervention
Group B: Treatment Arm BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR by independent central review
defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR
Time frame
12 months after the study completionSecondary outcomes
1
DoR by independent review
defined as time from the first documentation of response to the first documentation of objective tumor progression by ICR (per RECIST 1.1) or death due to any cause, whichever occurs first
Time frame
up to 12 months after the study completion2
PFS by independent review
defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first
Time frame
up to 12 months after the study completion3
ORR per Investigator assessment
defined as proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST v1.1).
Time frame
up to 12 months after the study completion4
DoR per Investigator assessment
defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
Time frame
up to 12 months after the study completionSponsors and contacts
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Source ClinicalTrials.gov