Advanced cholangiocarcinoma
Conditions
Brief summary
ORR by independent central review defined as the proportion of patients experiencing a best overall response ofpartial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR"
Detailed description
Duration of response (DoR) by BICR, Progression-free survival (PFS) by BICR, ORR, DoR, and PFS by investigator assessment, Overall survival (OS), Safety based on AEs (in particular ≥Grade 3), SAEs, dose modifications, clinical laboratory parameters, ophthalmological exams, and vital signs, PROs measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EuroQol-5D (EQ-5D)
Interventions
DRUGFutibatinib
Sponsors
Taiho Oncology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR by independent central review defined as the proportion of patients experiencing a best overall response ofpartial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR" | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) by BICR, Progression-free survival (PFS) by BICR, ORR, DoR, and PFS by investigator assessment, Overall survival (OS), Safety based on AEs (in particular ≥Grade 3), SAEs, dose modifications, clinical laboratory parameters, ophthalmological exams, and vital signs, PROs measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EuroQol-5D (EQ-5D) | — |
Countries
Italy, Poland, Portugal, Spain
Outcome results
None listed