Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
- Expanded Access
- Active
- NCT04507503
Contact Information
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
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.
Gender
All
Age Group
18 Years and up
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
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