Clinical Trials /

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

NCT02688881

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors
  • Official Title: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 2016-02-052
  • NCT ID: NCT02688881

Conditions

  • Refractory Solid Tumors

Interventions

DrugSynonymsArms
sirolimussirolimus

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
sirolimusExperimentalsirolimus 1mg will be administered orally daily
  • sirolimus

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free survival
Time Frame:6 Weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:24 months
Safety Issue:
Description:
Measure:Time to progression
Time Frame:24 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:24 months
Safety Issue:
Description:
Measure:Number of subjects with Adverse Events as a measure of safety
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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