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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 : Available
First Posted : August 11, 2020
Last Update Posted : September 22, 2021
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
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


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: Madappa Kundrandra, MD    480-440-7458    Madappa.kundranda@bannerhealth.com   
Principal Investigator: Kundrandra, MD         
United States, California
University of California, San Francisco (UCSF) Available
San Francisco, California, United States, 94143
Contact: Robin R Kelly, MD    877-827-3222    cancertrials@ucsf.edu   
Contact: Sneha Nalla    415-353-7284    Sneha.Nalla@ucsf.edu   
Principal Investigator: Kelly         
UCLA Division of Hematology-Oncology Available
Santa Monica, California, United States, 90404
Principal Investigator: 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: Cusnir         
United States, Illinois
University of Chicago Available
Chicago, Illinois, United States, 60637
Principal Investigator: 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: 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: Goyal         
Dana Farber Cancer Institute Available
Boston, Massachusetts, United States, 02215
Contact: GI Research Nursing    617-632-3000    DFCIGCCRNRS@partners.org   
Principal Investigator: 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: Chuda, MD         
United States, Texas
MD Anderson Available
Houston, Texas, United States, 77030
Contact: Funda Meric-Bernstam    713-794-1226    fmeric@mdanderson.org   
Principal Investigator: Meric-Bernstam         
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: Harris         
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: September 22, 2021
Last Verified: September 2021
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