Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors
NCT02449538 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2017-02-17
Summary
This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
Everolimus 10 mg will be administered orally qd daily.
To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.
Conditions
Interventions
- DRUG
-
everolimus 10 mg qd daily one cycle is 28days.
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Principal Investigators
-
Jee yun Lee, MD,Ph.D. · Samsung Medical Center,Seoul,Korea
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2016-04-30
- Completion
- 2016-08-31
Countries
- South Korea
Study Locations
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