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

NCT02688881 | Completed Phase 4 FDA Drug

• 1 other identifier: 2016-02-052
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Progression Free survival

  6 Weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

sirolimus

EXPERIMENTAL

sirolimus 1mg will be administered orally daily

Drug: sirolimus

Interventions

sirolimus DRUG

Rapamune

sirolimus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 99999, South Korea

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: February 5, 2017
• Primary Completion: December 30, 2020
• Study Completion: February 24, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)