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NCT05727176 · ClinicalTrials.gov registry record · Phase 2
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
A Phase 2 study of Advanced Cholangiocarcinoma and FGFR2 Fusions, sponsored by Taiho Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05727176: Recruiting Phase 2 study of Advanced Cholangiocarcinoma and FGFR2 Fusions, sponsored by Taiho Oncology.
NCT05727176 is a Phase 2 study of Advanced Cholangiocarcinoma and FGFR2 Fusions that is actively recruiting participants, run by Taiho Oncology. The registered enrollment target is 120 participants, above the 83-participant average among 3 other Advanced Cholangiocarcinoma trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05727176, a Phase 2 study of Advanced Cholangiocarcinoma and FGFR2 Fusions, is actively recruiting participants, sponsored by Taiho Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05727176 shows while recruiting
NCT05727176 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 83-participant average among 3 other Advanced Cholangiocarcinoma trials with a reported enrollment target (45% higher).
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.
NCT05727176 names 20 study sites across 9 states, led by Other, Texas, California.
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.
What interventions are being tested in trial NCT05727176?
The interventions under investigation include: TAS-120 (DRUG).
Who is sponsoring clinical trial NCT05727176?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
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.
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