Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Study Overview
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Brief Summary
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This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors . Everolimus 10 mg will be administered orally qd daily. To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: everolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of fully informed consent prior to any study specific procedures. Patients must be ≥20 years of age. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy. 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 ≥ 75 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. KRAS mutation (codon 12 or 13) or BRAF mutation (V600) Any previous treatment with everolimus

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus<br>everolimus 10 mg qd daily | Drug: everolimus<br>* everolimus 10 mg qd daily one cycle is 28days.<br>* Other names: RAD001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 24 weeks | 
| overall survival |  | 24 weeks | 
| Number of subjects with Adverse Events as a measure of toxicity profile |  | 24 weeks |