Clinical trial NCT04507503: Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Official title: An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Advanced Cholangiocarcinoma
Keywords: Cholangiocarcinoma
CCA
FGFR2 Gene Rearrangements
TAS-120
Futibatinib
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The objective of the study 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.

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)
5. Pregnant or breast-feeding female

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Santa Monica
country: United States
facility: UCLA Division of Hematology-Oncology
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Center of Florida
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Lee's Summit
country: United States
facility: University of Kansas Cancer Center
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Grafton
country: United States
facility: Aurora Cancer care
state: Wisconsin
Study officials:
References: