Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02449538|
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : February 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||August 2016|
everolimus 10 mg qd daily
everolimus 10 mg qd daily one cycle is 28days.
Other Name: RAD001
- overall response rate [ Time Frame: 24 weeks ]
- progression free survival [ Time Frame: 24 weeks ]
- overall survival [ Time Frame: 24 weeks ]
- Number of subjects with Adverse Events as a measure of toxicity profile [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449538
|Korea, Republic of|
|Samsung Medical center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Jee yun Lee, MD,Ph.D.||Samsung Medical Center,Seoul,Korea|