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

Refractory Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688881
• Other study ID #: 2016-02-052
• Status: Completed
• Phase: Phase 4
• Start date: February 5, 2017
• Est. completion date: February 24, 2021

Study information

• Verified date: June 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 24, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Refractory Solid Tumors

Intervention

Drug:
• sirolimus
Rapamune

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free survival		6 Weeks
Secondary	Overall Response Rate		24 months
Secondary	Time to progression		24 months
Secondary	Overall survival		24 months
Secondary	Number of subjects with Adverse Events as a measure of safety		24 months