Refractory Solid Tumors
Conditions
Brief summary
This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.
Interventions
DRUGsirolimus
Rapamune
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of fully informed consent prior to study specific procedures. * Patients must be \>= 19 years of age * Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * ECOG Performance status0-2 * Have measurable or evaluated disease based on RECIST 1.1 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 subject with liver metastases) Creatinine\<= 1.5 X UNL * Patients of child-bearing potential should be using adequate contraceptive measures 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 tumor 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 * Any previous treatment with sirolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free survival | 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate | 24 months |
| Time to progression | 24 months |
| Overall survival | 24 months |
| Number of subjects with Adverse Events as a measure of safety | 24 months |
Countries
South Korea
Outcome results
None listed