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

The primary purpose of this study is to investigate the safety of Tasfygo.

Recruiting

Interested in participating?

Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

#Eisai Trial Site 1

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

Number of Participants With Adverse Drug Reactions

Time frame: Up to 1 year

Secondary outcomes

Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment

Time frame: Up to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Inquiry Service

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2032
Study completion: 2032
First posted: Jan 27, 2025
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting