Phase I/II study of TAS-117 in combination with TAS-120
- Conditions
- Advanced solid tumors
- Registration Number
- JPRN-jRCT2080224785
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 137
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety, Efficacy
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>Safety, Efficacy, Pharmacokinetics analysis, Pharmacodynamics analysis