K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Inclusion criteria

• Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
• Progressive disease who failed to previous standard treatment.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
• Eastern Cooperative Oncology Group performance status 0 or 1
• Able to take medications orally
• Adequate organ function
• A life expectancy of at least 60 days

Exclusion criteria

• Previous treatment with anti-PI3K or AKT directed therapies
• Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
• History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
• Current evidence of retinopathy that requires ophthalmological therapy.
• History or current evidence of cardiac arrhythmia and/or conduction abnormality.
• Treatment with any of the following within the specified time frame prior to study drug administration:

• Major surgery within prior 4 weeks
• Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
• Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
• A serious illness or medical condition(s)
• Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
• Patients with the risk of hypokalemia
• Receiving oral steroid medication.
• Pregnant or lactating female