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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00519324
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Everolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
Study Start Date : August 2007
Actual Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

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

Primary Outcome Measures :
  1. To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) assessed by RECIST criteria [ Time Frame: 18 months ]
  2. To assess progression free survival (PFS) and overall survival (OS) [ Time Frame: 18 months ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00519324

Novartis investigative Site
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00519324     History of Changes
Other Study ID Numbers: CRAD001C1201
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents