NCT06793709

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
80mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jul 2025Nov 2032

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2032

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7.4 years

First QC Date

January 21, 2025

Last Update Submit

February 25, 2026

Conditions

Biliary Tract Cancer

Keywords

TasfygoFGFR2 fusionCancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Drug Reactions

    Up to 1 year

Secondary Outcomes (1)

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

    Up to 1 year

Study Arms (1)

Tasfygo tablet 35 milligrams (mg)

Other: No Intervention

Interventions

No InterventionOTHER

This is a non-interventional study.

Tasfygo tablet 35 milligrams (mg)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with FGFR2 fusion positive unresectable biliary tract cancer with prior chemotherapy who will receive Tasfygo tablet as per daily practice and package insert will be enrolled.

You may qualify if:

  • \. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

#Eisai Trial Site 1

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Biliary Tract NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Eisai Inquiry Service

CONTACT

eisai-chiken_hotline@hhc.eisai.co.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

November 20, 2032

Study Completion (Estimated)

November 20, 2032

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Locations

JP(1)