Advanced Gastric Cancer
Conditions
Keywords
Gastric Cancer, RAD001, mTOR
Brief summary
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.
Interventions
DRUGEverolimus
10 mg/day (2 tablets of 5 mg each)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological proven gastric adenocarcinoma * Progressive disease during/ after prior treatment * Treated with 1 or 2 chemotherapy regimen for advanced disease * At least one measurable lesion by RECIST criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* History of another primary malignancy within 3 years * Treated with 3 or more regimens for advanced gastric cancer * Chronic treatment with steroids or another immunosuppressive agent * A known history of HIV or hepatitis B seropositive, or active hepatitis C infection * Patients with active, bleeding diathesis Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by RECIST criteria | 18 months |
| To assess progression free survival (PFS) and overall survival (OS) | 18 months |
| To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0 | 18 months |
Countries
Japan
Outcome results
None listed