SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02688881

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT02688881 Refractory Solid Tumors

1 Interventions

Name: sirolimus

Description: Rapamune

Type: Drug

sirolimus


Primary Outcomes

Measure: Progression Free survival

Time: 6 Weeks

Secondary Outcomes

Measure: Overall Response Rate

Time: 24 months

Measure: Time to progression

Time: 24 months

Measure: Overall survival

Time: 24 months

Measure: Number of subjects with Adverse Events as a measure of safety

Time: 24 months

Purpose: Treatment

Single Group Assignment


There are 3 SNPs

SNPs


1 E542K

- 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. --- H1047R --- --- E542K ---


2 E545K

- 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. --- H1047R --- --- E542K --- --- E545K ---


3 H1047R

- 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. --- H1047R ---



HPO Nodes