Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT05727176 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG TAS-120

Study Locations (20)

Other

  • Hospital Britanico — Buenos Aires
  • CEMIC — CABA
  • Sanatorio de la Mujer — Rosario
  • Instituto do Cancer do Estado de Sao Paulo — Cerqueira César
  • IOP - Instituto de Oncologia do Parana — Curitiba
  • Hospital Erasto Gaertner — Curitiba
  • Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto

Texas

  • Texas Oncology — Abilene
  • The Liver Institute at Methodist Dallas Medical Center — Dallas
  • Texas Oncology Methodist DFW — Dallas
  • Texas Onc Methodist (Charlton) — Dallas
  • Texas Oncology - Northeast — Denton
  • Center for Oncology and Blood Disorders — Houston

California

  • University of California San Diego UCSD - Moores Cancer Center — La Jolla

Florida

  • Tampa General Hospital Cancer Institute — Tampa

Michigan

  • Henry Ford Health System — Detroit

Ohio

  • Gabrail Cancer Center Research — Canton

New South Wales

  • St Vincent's Hospital Sydney - The Kinghorn Cancer Centre — Sydney

Victoria

  • Alfred Health, Medical Oncology Unit, Second floor William Buckland Radiotherapy Center — Melbourne

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-07-05
Est. Completion 2026-12
Phase Phase 2

Sponsor

Taiho Oncology

46 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05727176

The ClinicalTrials.gov registry entry for NCT05727176 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Advanced Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention — of which TAS-120 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05727176 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05727176 about?

NCT05727176 is a clinical study titled "Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement". 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.

What is the current status of trial NCT05727176?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-07-05. Estimated completion is 2026-12.

What conditions does trial NCT05727176 study?

This clinical trial studies the following conditions: Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05727176?

The interventions under investigation include: TAS-120 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05727176?

This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05727176 being conducted?

This trial has 20 study locations across California, Florida, Michigan, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial