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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02688881

Collaborator

(none)

Enrollment

Location

Arm

48.6

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Solid Tumors	Drug: sirolimus	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 5, 2017

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Feb 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sirolimus sirolimus 1mg will be administered orally daily	Drug: sirolimus Rapamune

Arm

Intervention/Treatment

Experimental: sirolimus

sirolimus 1mg will be administered orally daily

Drug: sirolimus

Rapamune

Outcome Measures

Primary Outcome Measures

Progression Free survival [6 Weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	99999

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeeyun Lee, MD,PhD, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT02688881

Other Study ID Numbers:

2016-02-052

First Posted:

Feb 23, 2016

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Neoplasms

Sirolimus

Study Results

No Results Posted as of Jun 15, 2022