A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Advanced Gastric Cancer
Both
Advanced Gastric Cancer
Trial Information
A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
Inclusion Criteria
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/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
CRAD001C1201
NCT ID:
NCT00519324
Start Date:
August 2007
Completion Date:
Related Keywords:
- Advanced Gastric Cancer
- Gastric Cancer
- RAD001
- mTOR
- Stomach Neoplasms
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