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

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

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

Approved for marketing
Treatment IND/Protocol
Advanced Cholangiocarcinoma

Drug: TAS-120

Futibatinib 20mg QD orally on a 28 days cycle
Other Name: Futibatinib

Eligibility Criteria

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:

1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus

2. History and/or current evidence of clinically significant ectopic

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Banner MD Anderson
Gilbert, Arizona, United States

University of California, San Francisco (UCSF)
San Francisco, California, United States

UCLA Division of Hematology-Oncology
Santa Monica, California, United States

Mount Sinai Center of Florida
Miami Beach, Florida, United States

Advent Health Orlando
Orlando, Florida, United States

University of Chicago
Chicago, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

Dana Farber Cancer Institute
Boston, Massachusetts, United States

University of Kansas Cancer Center
Lee's Summit, Missouri, United States

Duke University Medical Center
Durham, North Carolina, United States

Providence Portland Medical Center
Portland, Oregon, United States

MD Anderson
Houston, Texas, United States

Utah Cancer Specialists
Salt Lake City, Utah, United States

Seattle Cancer Care Alliance
Seattle, Washington, United States

Aurora Cancer care
Grafton, Wisconsin, United States

Taiho Oncology, Inc.
NCT Number
FGFR2 Gene Rearrangements
MeSH Terms