NCT04507503

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Geographic Reach
1 country

16 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

First QC Date

August 7, 2020

Last Update Submit

March 9, 2026

Conditions

Keywords

CholangiocarcinomaCCAFGFR2 Gene RearrangementsTAS-120Futibatinib

Interventions

Futibatinib 20mg QD orally on a 28 days cycle

Also known as: Futibatinib

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Has measurable or non-measurable lesion(s).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate organ function.

You may not qualify if:

  • 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)
  • Pregnant or breast-feeding female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Banner MD Anderson

Gilbert, Arizona, 85234, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

UCLA Division of Hematology-Oncology

Santa Monica, California, 90404, United States

Location

Mount Sinai Center of Florida

Miami Beach, Florida, 33140, United States

Location

Advent Health Orlando

Orlando, Florida, 32804, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Kansas Cancer Center

Lee's Summit, Missouri, 64064, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Aurora Cancer care

Grafton, Wisconsin, 53024, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

futibatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations