Advanced solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : TAS-117
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent. 2. Male or female who are more than 20 years at enrollment. 3. Histologically or cytologically confirmed advanced or metastatic solid tumor(s). Phase 1: Patients with advanced solid tumor for whom no standard treatment remains harboring FGF, FGFR, PTEN, PIK3CA or AKT gene alteration. Phase 2, part 1: Patients with squamous cell lung cancer harboring FGFR1 gene amplification. Phase 2, part 2: Patients with solid tumor harboring FGFR gene alteration. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient allocation. 5. Able to take medications orally. 6. Adequate organ function as defined by the following criteria: random glucose is less than 200 mg/dL, HbA1c is less than 8.0%, LDL cholesterol is less than 190 mg/dL, triglycerides is less than 300 mg/dL, AST and ALT are less than 3.0 times upper limit of normal (ULN), if liver function abnormalities are due to underlying liver metastasis, AST and ALT are less than 5 times ULN, total serum bilirubin is less than 1.5 times ULN, or less than 3.0 mg/dL for patients with Gilbert syndrome, absolute neutrophil count is more than 1500/mm3, platelet count is more than 75000/mm3, hemoglobin value is more than 8.0 g/dL, SpO2 is more than 90%, creatinine clearance is more than 50 mL/min, Pi is less than ULN.
Exclusion criteria
Exclusion criteria: 1. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy. 2. History or current evidence of clinically significant retinopathy that requires ophthalmological therapy. 3. History or current evidence of clinically significant retinopathy and/or corneal disorder confirmed by ophthalmological examination. 4. HBs antigen-positive, HBs antibody-positive or HBc antibody-positive (but if HBs antibody-positive or HBc antibody-positive with HBV DNA-negative, the patient can be enrolled). 5. HCV antibody-positive (but if HCV antibody-positive with HCV RNA-negative, the patient can be enrolled). 6. Patients with known diagnosis of HIV infection. 7. Any clinically significant acute/chronic medical or psychiatric condition(s), or any abnormal laboratory test result including, but not limited to, the following: a. Known brain metastasis not stable off steroids for more than 2 months. b. Known leptomeningeal metastasis. c. Known acute systemic infection. d. Known myocardial infarction, severe/unstable angina, symptomatic congestive heart failure within the previous 6 months. e. History or current evidence of interstitial lung disease that requires steroid medication. 8. Unresolved toxicity of less than Grade 1 attributed to any prior therapies, excluding alopecia, skin pigmentation and anemia. 9. Prior therapy with TAS 117. 10. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Safety, Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics Safety, Efficacy, Pharmacokinetics analysis, Pharmacodynamics analysis | — |
Countries
Japan
Outcome results
None listed