Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors
NCT02688881 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2022-06-15
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
- DRUG
-
sirolimus
Rapamune
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-05
- Primary Completion
- 2020-12-30
- Completion
- 2021-02-24
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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