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

Sponsor: Taiho Oncology, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04507503

Patient View

This open-label study offers TAS-120 to patients with advanced cholangiocarcinoma who have FGFR2 gene rearrangements and have not responded to or cannot tolerate standard therapy. Eligible participants must be over 18, have confirmed CCA, and meet specific health criteria. The intervention involves taking 20mg of Futibatinib orally in 28-day cycles.

Patient Parameters

Program Overview

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

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

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