Status:
APPROVED_FOR_MARKETING
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Cholangiocarcinoma
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04507503
Last Update
January 7 2025
Active Locations (16)
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1
Banner MD Anderson
Gilbert, Arizona, United States, 85234
2
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
3
UCLA Division of Hematology-Oncology
Santa Monica, California, United States, 90404
4
Mount Sinai Center of Florida
Miami Beach, Florida, United States, 33140