The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

Inclusion criteria

• Provision of fully informed consent prior to any study specific procedures.
• Patients must be ≥20 years of age.
• PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors.
• ECOG performance status 0-2.
• Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
• Adequate Organ Function Laboratory Values

• Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
• bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
• creatinine ≤1.5 x UNL
• Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
• Adequate heart function.

Exclusion criteria

• Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
• Has known active central nervous system (CNS) metastases.
• Has an active infection requiring systemic therapy.
• Pregnancy or breast feeding
• Patients with cardiac problem.