Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Samsung Medical Center

Status and phase

Completed

Phase 4

Conditions

Refractory Solid Tumors

Treatments

Drug: sirolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT02688881

2016-02-052

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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