Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator
by Kelly

Description

Summary

The objective of the program is to provide access to TAS-120 to 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

Details

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.

Keywords

Advanced Cholangiocarcinoma Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib Cholangiocarcinoma TAS-120

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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)

Locations

  • University of California, San Francisco (UCSF) not accepting new patients
    San Francisco California 94143 United States
  • UCLA Division of Hematology-Oncology not accepting new patients
    Santa Monica California 90404 United States

Lead Scientist at UCSF

Details

Status
not accepting new patients
Start Date
Sponsor
Taiho Oncology, Inc.
ID
NCT04507503
Study Type
Expanded Access
Last Updated