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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04507503
Expanded Access Status : Approved for marketing
First Posted : August 11, 2020
Last Update Posted : August 16, 2023
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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.

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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



Intervention Details:
  • Drug: TAS-120
    Futibatinib 20mg QD orally on a 28 days cycle
    Other Name: Futibatinib

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:

  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 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

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.
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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: August 16, 2023
Last Verified: August 2023
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