Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Male or female patients > 18 years old

• Histologically or cytologically confirmed and documented gastric adenocarcinoma

• Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease

• ECOG Performance Status of < 2

• Lab parameters within specifically defined intervals

• Able to provide written informed consent

Exclusion Criteria:

• Patients who have received > 2 prior systemic therapies for advanced disease

• Administration of another anticancer therapy within 3 weeks prior to randomization

• Chronic treatment with steroids or another immunosuppressive agent

• Major surgery within 2 weeks prior to randomization

• Patients with CNS metastases

• Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply