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

November 16, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Novartis Investigative Site
      • Chiba, Japan
        • Novartis Investigative Site
      • Ehime, Japan
        • Novartis Investigative Site
      • Hokkaido, Japan
        • Novartis Investigative Site
      • Osaka, Japan
        • Novartis Investigative Site
      • Shizuoka, Japan
        • Novartis Investigative Site
      • Tochigi, Japan
        • Novartis Investigative Site
      • Tokyo, Japan
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD001
Drug: Everolimus
10 mg/day (2 tablets of 5 mg each)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) assessed by RECIST criteria
Time Frame: 18 months
18 months
To assess progression free survival (PFS) and overall survival (OS)
Time Frame: 18 months
18 months
To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C1201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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