Completed

An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is eligible

Adenocarcinoma+3

+ Carcinoma

+ Neoplasms

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is it accessible

Completed

Available upon a request by a licensed MD
Expanded Access
See protocol details

Summary

Principal SponsorTaiho Oncology, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.

Official TitleAn Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
NCT04507503
Principal SponsorTaiho Oncology, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

AdenocarcinomaCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialCholangiocarcinoma

Criteria

7 inclusion criteria required to participate
Provide written informed consent.

18 years of age.

Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.

Patient has failed standard therapy or standard therapy is not tolerated.

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5 exclusion criteria prevent from participating
History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.

History and/or current evidence of clinically significant ectopic mineralization/calcification.

History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.

A serious illness or medical condition(s)

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Suspended

Banner MD Anderson

Gilbert, United StatesOpen Banner MD Anderson in Google Maps
Suspended

University of California, San Francisco (UCSF)

San Francisco, United States
Suspended

UCLA Division of Hematology-Oncology

Santa Monica, United States
Suspended

Mount Sinai Center of Florida

Miami Beach, United States
Completed16 Study Centers