Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

Novartis

Status and phase: Completed; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519324

CRAD001C1201

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

RAD001

Experimental group

Treatment:

Drug: Everolimus