Completed
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
What is being tested
Data Collection
Who is eligible
Adenocarcinoma+3
+ Carcinoma
+ Neoplasms
Over 18 Years
+12 Eligibility Criteria
How is it accessible
Completed
Available upon a request by a licensed MDExpanded Access
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
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
Suspended
University of California, San Francisco (UCSF)
San Francisco, United StatesSuspended
UCLA Division of Hematology-Oncology
Santa Monica, United StatesSuspended
Mount Sinai Center of Florida
Miami Beach, United StatesCompleted16 Study Centers