Solid Tumors
Conditions
Brief summary
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Detailed description
Safety based on AEs, SAEs, dose modifications, clinical laboratory parameters, vital signs, electrocardiograms (ECGs), and ophthalmological exams, Duration of response (DoR) by investigator assessment, Disease control rate (DCR) by investigator assessment, Progression-free survival (PFS) by investigator assessment, 6-month PFS rate by investigator assessment
Interventions
DRUGCISPLATIN
DRUGFutibatinib
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGFLUOROURACIL
DRUGOXALIPLATIN
Sponsors
Taiho Oncology Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety based on AEs, SAEs, dose modifications, clinical laboratory parameters, vital signs, electrocardiograms (ECGs), and ophthalmological exams, Duration of response (DoR) by investigator assessment, Disease control rate (DCR) by investigator assessment, Progression-free survival (PFS) by investigator assessment, 6-month PFS rate by investigator assessment | — |
Countries
France, Germany, Spain
Outcome results
None listed