The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
10 mg/day (2 tablets of 5 mg each)
Novartis investigative Site
Aichi, Japan
Novartis investigative Site
Chiba, Japan
Novartis investigative Site
Ehime, Japan
Novartis Investigative Site
Hokkaido, Japan
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time frame: 18 months
Objective response rate (ORR) assessed by RECIST criteria
Time frame: 18 months
To assess progression free survival (PFS) and overall survival (OS)
Time frame: 18 months
To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0
Time frame: 18 months
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Novartis investigative Site
Osaka, Japan
Novartis investigative Site
Shizuoka, Japan
Novartis Investigative Site
Tochigi, Japan
Novartis investigative Site
Tokyo, Japan