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

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ClinicalTrials.gov Identifier: NCT04507503

Expanded Access Status : Approved for marketing

First Posted : August 11, 2020

Last Update Posted : February 23, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Taiho Oncology, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Advanced Cholangiocarcinoma	Drug: TAS-120

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.

Study Design

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Study Type :	Expanded Access
Expanded Access Type :	Treatment IND/Protocol
	See clinical trials of the intervention/treatment in this expanded access record.
Official Title:	An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Crouzon syndrome Cholangiocarcinoma Pfeiffer syndrome Jackson-Weiss syndrome

MedlinePlus related topics: Genes and Gene Therapy

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer Crouzon Syndrome Jackson-Weiss Syndrome Pfeiffer Syndrome

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: TAS-120
Futibatinib 20mg QD orally on a 28 days cycle

Other Name: Futibatinib

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507503

Locations

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

Sponsors and Collaborators

Taiho Oncology, Inc.

More Information

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Responsible Party:	Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT04507503
Other Study ID Numbers:	TAS-120-401
First Posted:	August 11, 2020 Key Record Dates
Last Update Posted:	February 23, 2024
Last Verified:	February 2024

Keywords provided by Taiho Oncology, Inc.:


Cholangiocarcinoma CCA FGFR2 Gene Rearrangements TAS-120 Futibatinib

Additional relevant MeSH terms:

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Cholangiocarcinoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial	Neoplasms by Histologic Type Neoplasms Futibatinib Antineoplastic Agents

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