Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
NCT ID: NCT04507503
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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TAS-120
Futibatinib 20mg QD orally on a 28 days cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Taiho Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TAS-120-401
Identifier Type: -
Identifier Source: org_study_id
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