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

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Everolimus

• Registration Number: NCT00519324
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Primary Completion: 2009-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RAD001	Everolimus	-

Primary Outcome Measures

Name	Time	Method
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria	18 months

Secondary Outcome Measures

Name	Time	Method
To assess progression free survival (PFS) and overall survival (OS)	18 months
Objective response rate (ORR) assessed by RECIST criteria	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

Trial Locations

Locations (2)

Novartis Investigative Site; 🇯🇵 Tochigi, Japan

Novartis investigative Site; 🇯🇵 Tokyo, Japan