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Approved for marketingNCT04507503Updated Mar 10, 2026

Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

An expanded access record providing TAS-120 in Advanced Cholangiocarcinoma, sponsored by Taiho Oncology, Inc.. Approved for marketing at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Taiho Oncology, Inc. · Expanded access

Study type
Expanded access
Access type
Treatment IND/protocol
Ages
18 Years and older
Sex
All
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Study summary

The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

Read the detailed description

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.

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Conditions studied

  • Advanced Cholangiocarcinoma

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Keywords

  • Cholangiocarcinoma
  • CCA
  • FGFR2 Gene Rearrangements
  • TAS-120
  • Futibatinib
03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

Browse Cholangiocarcinoma studies →

Lead sponsor

Taiho Oncology, Inc. is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  1. Provide written informed consent.
  2. >18 years of age.
  3. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.
  4. Patient has failed standard therapy or standard therapy is not tolerated.
  5. Has measurable or non-measurable lesion(s).
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  7. Adequate organ function.

Exclusion criteria

Exclusion Criteria:

  1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
  2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
  3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
  4. A serious illness or medical condition(s)
  5. Pregnant or breast-feeding female
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Access details

Study type
Expanded access
Access type
Treatment IND/protocol

Available treatment

  • DrugTAS-120

    Futibatinib 20mg QD orally on a 28 days cycle

    Also known as: Futibatinib

06

Where to request access

16 sites
  • Banner MD Anderson
    Gilbert, Arizona 85234, United States
  • University of California, San Francisco (UCSF)
    San Francisco, California 94143, United States
  • UCLA Division of Hematology-Oncology
    Santa Monica, California 90404, United States
  • Mount Sinai Center of Florida
    Miami Beach, Florida 33140, United States
  • Advent Health Orlando
    Orlando, Florida 32804, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • University of Kansas Cancer Center
    Lee's Summit, Missouri 64064, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • MD Anderson
    Houston, Texas 77030, United States
  • Utah Cancer Specialists
    Salt Lake City, Utah 84106, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • Aurora Cancer care
    Grafton, Wisconsin 53024, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04507503
Lead sponsor
Taiho Oncology, Inc.
Responsible party
Sponsor
First posted
Aug 11, 2020
Last update
Mar 10, 2026
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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