Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
- Conditions
- Advanced Cholangiocarcinoma
- Registration Number
- NCT04507503
- Lead Sponsor
- Taiho Oncology, Inc.
- 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.
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Banner MD Anderson
🇺🇸Gilbert, Arizona, United States
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
UCLA Division of Hematology-Oncology
🇺🇸Santa Monica, California, United States
Mount Sinai Center of Florida
🇺🇸Miami Beach, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Kansas Cancer Center
🇺🇸Lee's Summit, Missouri, United States
Scroll for more (6 remaining)Banner MD Anderson🇺🇸Gilbert, Arizona, United States