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Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Primary Purpose

Advanced Cholangiocarcinoma

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TAS-120
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Advanced Cholangiocarcinoma focused on measuring Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Banner MD Anderson
  • University of California, San Francisco (UCSF)
  • UCLA Division of Hematology-Oncology
  • Mount Sinai Center of Florida
  • Advent Health Orlando
  • University of Chicago
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital
  • Dana Farber Cancer Institute
  • University of Kansas Cancer Center
  • Duke University Medical Center
  • Providence Portland Medical Center
  • MD Anderson
  • Utah Cancer Specialists
  • Seattle Cancer Care Alliance
  • Aurora Cancer care

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 7, 2020
Last Updated
August 15, 2023
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04507503
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cholangiocarcinoma
Keywords
Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TAS-120
Other Intervention Name(s)
Futibatinib
Intervention Description
Futibatinib 20mg QD orally on a 28 days cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Provide written informed consent. >18 years of age. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory. Patient has failed standard therapy or standard therapy is not tolerated. Has measurable or non-measurable lesion(s). Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Adequate organ function. Exclusion Criteria: History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. History and/or current evidence of clinically significant ectopic mineralization/calcification. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. A serious illness or medical condition(s) Pregnant or breast-feeding female
Facility Information:
Facility Name
Banner MD Anderson
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
University of California, San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCLA Division of Hematology-Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mount Sinai Center of Florida
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Kansas Cancer Center
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Aurora Cancer care
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

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