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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 22, 2007
Last Update Posted: November 18, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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 Intervention Phase
Advanced Gastric Cancer Drug: Everolimus Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

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

Enrollment: 54
Study Start Date: August 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: Everolimus
10 mg/day (2 tablets of 5 mg each)


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

  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00519324     History of Changes
Other Study ID Numbers: CRAD001C1201
First Submitted: August 21, 2007
First Posted: August 22, 2007
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