FindTrial
Sign In

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

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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04507503
Enrollment
Unknown
Registered
2020-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cholangiocarcinoma

Keywords

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

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.

Interventions

DRUGTAS-120

Futibatinib 20mg QD orally on a 28 days cycle

Sponsors

Taiho Oncology, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026