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

Phase 4

Completed

• Conditions: Refractory Solid Tumors
• Interventions: Drug: sirolimus

• Registration Number: NCT02688881
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-23
• Study Start: 2017-02-05
• Primary Completion: 2020-12-30
• Study Completion: 2021-02-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sirolimus	sirolimus	sirolimus 1mg will be administered orally daily

Primary Outcome Measures

Name	Time	Method
Progression Free survival	6 Weeks

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	24 months
Overall survival	24 months
Time to progression	24 months
Number of subjects with Adverse Events as a measure of safety	24 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of