Official Title
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Brief Summary

The objective of the program is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

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.

Available
Treatment IND/Protocol
Advanced Cholangiocarcinoma

Drug: TAS-120
Futibatinib 20mg QD orally on a 28 days cycle
Other Name: Futibatinib

Eligibility 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Banner MD Anderson
Gilbert, Arizona, 85234

Available

Investigator: Madappa Kundrandra, MD
Contact: 480-440-7458
Madappa.kundranda@bannerhealth.com

Investigator: Kundrandra, MD

University of California, San Francisco (UCSF)
San Francisco, California, 94143

Available

Investigator: Robin R Kelly, MD
Contact: 877-827-3222
cancertrials@ucsf.edu


Investigator: Sneha Nalla
Contact: 415-353-7284
Sneha.Nalla@ucsf.edu

Investigator: Kelly

UCLA Division of Hematology-Oncology
Santa Monica, California, 90404

Available

Investigator: Rosen

Mount Sinai Center of Florida
Miami Beach, Florida, 33140

Available

Investigator: Yvonne Enriquez-Nunez
Contact: 305-674-2625
yenrique@msmc.com

Investigator: Cusnir

University of Chicago
Chicago, Illinois, 60637

Available

Investigator: Liao

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231

Available

Investigator: Nilofer Azad, MD
Contact: 410-614-1058
nazad2@jhmi.edu

Investigator: Azad, MD

Massachusetts General Hospital
Boston, Massachusetts, 02114

Available

Investigator: Patricia Lynch, RN
Contact: 617-643-0816
lynch.patricia2@mgh.harvard.edu

Investigator: Goyal

Dana Farber Cancer Institute
Boston, Massachusetts, 02215

Available

Investigator: GI Research Nursing
Contact: 617-632-3000
DFCIGCCRNRS@partners.org

Investigator: Cleary

University of Kansas Cancer Center
Lee's Summit, Missouri, 64064

Available

Investigator: Ravi Chuda, MD
Contact: 913-574-2350
rchuda@kumc.edu

Investigator: Chuda, MD

MD Anderson
Houston, Texas, 77030

Available

Investigator: Funda Meric-Bernstam
Contact: 713-794-1226
fmeric@mdanderson.org

Investigator: Meric-Bernstam

Seattle Cancer Care Alliance
Seattle, Washington, 98109

Available

Investigator: Tracey N Pierce
Contact: 206-606-7603
pierct@seattlecca.org

Investigator: Harris

Contacts

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

Taiho Oncology, Inc.
NCT Number
Keywords
Cholangiocarcinoma
CCA
FGFR2 Gene Rearrangements
TAS-120
Futibatinib
MeSH Terms
Cholangiocarcinoma
Intervention Name
TAS-120