Patients with advanced or metastatic esophageal carcinoma or non-small-cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : futibatinib
INN of investigational material : futibatinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Taiho Pharmaceutical Co., Ltd.
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Be willing and able to provide written informed consent for the trial. Able to take medications orally. Have a measurable disease per RECIST 1.1 Have adequate organ function value Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol procedures Feasibility phase Have histologically confirmed advanced or metastatic solid tumors Be positive for FGF/FGFR abnormalities Expansion phase Have histologically confirmed advanced or metastatic esophageal carcinoma or non-small cell lung cancer Have mRNA of FGFR 1, 2, 3, or 4 overexpression in tumor tissue sample (non-small cell lung cancer)
Exclusion criteria
Exclusion criteria: Have a serious illness or medical conditions. Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to futibatinib and any drug similar to futibatinib in structure or class
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Safety, Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Safety, Efficacy | — |
Countries
Japan
Outcome results
None listed