Phase I/II Study of TAS-117 in combination with TAS-120 in patients with advanced solid tumors

Taiho Pharmaceutical Co., Ltd.0 sites137 target enrollmentStarted: July 16, 2019Last updated: October 17, 2023

Conditions

Trial Snapshot

No summary available.

•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.

•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.

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