Actively Recruiting
Post-marketing Observational Study of Tasfygo Tablet 35 mg to Evaluate the Safety of Tasfygo in Patients With Unresectable Biliary Tract Cancer With FGFR2 Fusion Gene Positivity Who Progressed After Chemotherapy
Led by Eisai Co., Ltd. · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of Tasfygo in patients with unresectable biliary tract cancer who have a specific FGFR2 fusion gene and whose cancer has progressed after chemotherapy. This observational study aims to monitor how participants respond to Tasfygo in a real-world setting without altering their standard care. Participants will receive Tasfygo tablets at a dose of 35 mg as part of their normal treatment routine. Since this is a non-interventional study, researchers will not assign treatments but will observe and collect data on participants who are already prescribed Tasfygo. The study will follow participants for up to one year to assess safety and response. During the study, researchers will track the number of participants experiencing adverse drug reactions and assess the best overall response based on physicians' evaluations. Data will be collected through regular clinical assessments over the course of the year. Participants will continue their usual care alongside study observations, and the total participation time spans up to one year.
CONDITIONS
Brief Title
A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity
- Participants must be naive to Tasfygo tablet treatment
- Participants must have progressed after chemotherapy
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants who are using Tasfygo are observed to evaluate the safety and outcomes over time.
Regular visits during the observation period
Trial Site Locations
Total: 1 location
1
#Eisai Trial Site 1
Tokyo, Japan
Actively Recruiting
Research Team
E
Eisai Inquiry Service
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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