A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment

Novartis Pharmaceuticals2 sites in 1 country54 target enrollmentAugust 2007

ConditionsAdvanced Gastric Cancer

InterventionsEverolimus

DrugsEverolimus

Overview

Phase: Phase 2
Intervention: Everolimus
Conditions: Advanced Gastric Cancer
Sponsor: Novartis Pharmaceuticals
Enrollment: 54
Locations: 2
Primary Endpoint: To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

January 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

RAD001

Intervention: Everolimus

Outcomes

Primary Outcomes

To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria

Time Frame: 18 months

Secondary Outcomes

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)