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

Status:	Completed
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2009
End Date:	January 2014

A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy

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.

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

We found this trial at

sites

Novartis Investigative Site

Rio Negro, Viedma

from

Rio Negro,