NCT02688881

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	sirolimus	Rapamune

Timeline

• Start date: 2017-02-05
• Primary completion: 2020-12-30
• Completion: 2021-02-24
• First posted: 2016-02-23
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study