Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Part of paid clinical trials in La Jolla, California.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT05727176
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Fusions
  • Gene Rearrangement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAS-120 — DRUG
    TAS-120 is an oral FGFR inhibitor

Study 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.

Key Dates

Start date
Jul 5, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    TAS-120 (20mg) tablets, oral; 21-day cycle
  • Experimental: Treatment Arm B
    TAS-120 (16mg) tablets, oral; 21-day cycle

Primary Outcome Measure

ORR by independent central review [ Time Frame: 12 months after the study completion ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California San Diego UCSD - Moores Cancer CenterLa JollaCalifornia92093
[email protected]
858-657-7000
Burgoyne Adam (PRINCIPAL_INVESTIGATOR)
Tampa General Hospital Cancer InstituteTampaFlorida33606-
Henry Ford Health SystemDetroitMichigan48202
[email protected]
888-734-5322
Philip Philip (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718-
Texas OncologyAbileneTexas79606-5208
[email protected]
325-692-0188
Melynk Anton (PRINCIPAL_INVESTIGATOR)
Texas Onc Methodist (Charlton)DallasTexas75237-
Texas Oncology Methodist DFWDallasTexas75230-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203
[email protected]
214-947-4450
Parvez Mantry (PRINCIPAL_INVESTIGATOR)
Texas Oncology - NortheastDentonTexas76201-
Center for Oncology and Blood DisordersHoustonTexas77030-

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By research site
University of California San Diego UCSD - Moores Cancer Center· La Jolla, CATampa General Hospital Cancer Institute· Tampa, FLHenry Ford Health System· Detroit, MIGabrail Cancer Center Research· Canton, OHTexas Oncology· Abilene, TXTexas Onc Methodist (Charlton)· Dallas, TX

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