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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04507503
Expanded Access Status : Available
First Posted : August 11, 2020
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
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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


Interventions
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Intervention Details:
  • Drug: TAS-120
    Futibatinib 20mg QD orally on a 28 days cycle
    Other Name: Futibatinib
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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


Contacts
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Contact: Volker Wacheck, MD 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
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United States, Arizona
Banner MD Anderson Available
Gilbert, Arizona, United States, 85234
Contact    480-440-7458    Madappa.kundranda@bannerhealth.com   
Principal Investigator: Madappa Kundrandra, MD         
United States, California
University of California, San Francisco (UCSF) Available
San Francisco, California, United States, 94143
Contact: Robin R Kelley, MD    877-827-3222    cancertrials@ucsf.edu   
Contact: Sneha Nalla    415-353-7284    Sneha.Nalla@ucsf.edu   
Principal Investigator: Kelley         
UCLA Division of Hematology-Oncology Available
Santa Monica, California, United States, 90404
Contact    310-794-6500    ChristopherLim@mednet.ucla.edu   
Principal Investigator: Lee S Rosen         
United States, Florida
Mount Sinai Center of Florida Available
Miami Beach, Florida, United States, 33140
Contact: Yvonne Enriquez-Nunez    305-674-2625    yenrique@msmc.com   
Principal Investigator: Mike Cusnir         
Advent Health Orlando Available
Orlando, Florida, United States, 32804
Contact: Alejandra Ricaurte    407-303-7456    alejandra.ricaurte@adventhealth.com   
Principal Investigator: Mohamedtaki Tejani         
United States, Illinois
University of Chicago Available
Chicago, Illinois, United States, 60637
Contact: Aurelie Desgardin    773-204-7188    adesgard@medicine.bsd.uchicago.edu   
Principal Investigator: Chi-Yi Liao         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Available
Baltimore, Maryland, United States, 21231
Contact: Nilofer Azad, MD    410-614-1058    nazad2@jhmi.edu   
Principal Investigator: Nilofer Azad, MD         
United States, Massachusetts
Massachusetts General Hospital Available
Boston, Massachusetts, United States, 02114
Contact: Patricia Lynch, RN    617-643-0816    lynch.patricia2@mgh.harvard.edu   
Principal Investigator: Lipika Goyal         
Dana Farber Cancer Institute Available
Boston, Massachusetts, United States, 02215
Contact: GI Research Nursing    617-632-3000    DFCIGCCRNRS@partners.org   
Principal Investigator: James Cleary         
United States, Missouri
University of Kansas Cancer Center Available
Lee's Summit, Missouri, United States, 64064
Contact: Ravi Chuda, MD    913-574-2350    rchuda@kumc.edu   
Principal Investigator: Ravi Chuda, MD         
United States, North Carolina
Duke University Medical Center Available
Durham, North Carolina, United States, 27710
Contact: Niharika Mettu, MD    919-681-2945    Niharika.mettu@duke.edu   
Principal Investigator: Niharika Mettu, MD         
United States, Oregon
Providence Portland Medical Center Available
Portland, Oregon, United States, 97213
Contact: Providence Cancer Institute    503-215-2614    CanClinRsrchStudies@providence.org   
Principal Investigator: Gina Vaccaro         
United States, Texas
MD Anderson Available
Houston, Texas, United States, 77030
Contact: Funda Meric-Bernstam    713-794-1226    fmeric@mdanderson.org   
Principal Investigator: Funda Meric-Bernstam         
United States, Utah
Utah Cancer Specialists Available
Salt Lake City, Utah, United States, 84106
Contact: Johnny Walker    801-281-6864    jwalter@utahcancer.com   
Principal Investigator: Stephan Kendall         
United States, Washington
Seattle Cancer Care Alliance Available
Seattle, Washington, United States, 98109
Contact: Tracey N Pierce    206-606-7603    pierct@seattlecca.org   
Principal Investigator: Willliam Harris         
United States, Wisconsin
Aurora Research Institute Available
Grafton, Wisconsin, United States, 53024
Contact: J. Scott Maul    262-329-5000    jscott.maul@aah.org   
Principal Investigator: J. Scott Maul         
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: January 4, 2023
Last Verified: January 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