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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The primary purpose of this study is to investigate the safety of Tasfygo.
Interventions
- Other No Intervention
This is a non-interventional study.
Primary outcome measures
- Number of Participants With Adverse Drug Reactions [Time frame: Up to 1 year]
Secondary outcome measures (1)
- Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment [Time frame: Up to 1 year]
Eligibility criteria
Inclusion criteria
1\. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.
Exclusion criteria
Not applicable.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- #Eisai Trial Site 1 — Tokyo
Identifiers
NCT: NCT06793709 · E7090-M081-501