The objective of the study is to provide access to TAS-120 to patients With AdvancedCholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
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.
Drug: TAS-120
Futibatinib 20mg QD orally on a 28 days cycle
Other Name: Futibatinib
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
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