solid malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : TAS-120
INN of investigational material : TAS-120
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational ma
Sponsors
National Cancer Center Hospital East
Taiho Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent for participation in the study is obtained at the discretion of the patient. 2.The patient is 20 years of age or older on the date of informed consent. 3.Histologically or cytologically confirmed an unresectable advanced or recurrent solid malignancy without standard treatment remains. 4.The following genomic alteration is detected by analysis of blood sample using Guardant360: I.FGFR fusion II.FGFR amplification III.FGFR mutation 5.The disease is measurable based on the Response Evaluation Criteria in Solid Tumours (RECIST) guidelines version 1.1
Exclusion criteria
Exclusion criteria: 1.History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis. 2.History and/or current evidence of ectopic mineralization/calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification. 3.Current evidence of corneal disorder/keratopathy including but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination. 4.History or current evidence of cardiac arrhythmia and/or conduction abnormality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy objective response rate(ORR) assessed by investigators | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Progression-free survival(PFS),Duration of response(DoR), Time to treatment failure(TTF),Disease control rate(DCR),Overall survival(OS),ORR by central assessment(ORR),AE | — |
Countries
Japan
Outcome results
None listed