The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma 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, 85234
Contact: 480-440-7458
Investigator: Madappa Kundrandra, MD
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Investigator: Robin R Kelley, MD
Contact: 877-827-3222
Investigator: Sneha Nalla
Contact: 415-353-7284
Investigator: Kelley
UCLA Division of Hematology-Oncology
Santa Monica, California, 90404
Investigator: Rosen
Mount Sinai Center of Florida
Miami Beach, Florida, 33140
Investigator: Yvonne Enriquez-Nunez
Contact: 305-674-2625
Investigator: Cusnir
Advent Health Orlando
Orlando, Florida, 32803
Investigator: Alejandra Ricaurte
Contact: 407-303-7456
University of Chicago
Chicago, Illinois, 60637
Investigator: Liao
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Investigator: Nilofer Azad, MD
Contact: 410-614-1058
Investigator: Azad, MD
Massachusetts General Hospital
Boston, Massachusetts, 02114
Investigator: Patricia Lynch, RN
Contact: 617-643-0816
Investigator: Goyal
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Investigator: GI Research Nursing
Contact: 617-632-3000
Investigator: Cleary
University of Kansas Cancer Center
Lee's Summit, Missouri, 64064
Investigator: Ravi Chuda, MD
Contact: 913-574-2350
Investigator: Chuda, MD
Duke University Medical Center
Durham, North Carolina, 27710
Contact: 919-681-2945
Investigator: Niharika Mettu, MD
MD Anderson
Houston, Texas, 77030
Investigator: Funda Meric-Bernstam
Contact: 713-794-1226
Investigator: Meric-Bernstam
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Investigator: Tracey N Pierce
Contact: 206-606-7603
Investigator: Harris
Aurora Research Institute
Grafton, Wisconsin, 53024
Contact: 262-329-5000
Investigator: J. Scott Maul
Volker Wacheck, MD
609-250-7336
clinicaltrialinfo@taihooncology.com