Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00519324

Purpose

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 II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Disease control rate as defined CR + PR + SD assessed by RECIST criteria

Secondary Outcome Measures:

Objective response rate assessed by RECIST criteria Progression free survival and overall survival Safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0

Estimated Enrollment:	52
Study Start Date:	August 2007

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519324

Locations

Japan

Tokyo, Japan

Chiba, Japan

Shizuoka, Japan

Ehime, Japan

Osaka, Japan

Aichi, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CRAD001C1201
Study First Received:	August 21, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00519324
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Gastric Cancer
RAD001
mTOR

Study placed in the following topic categories:

Everolimus
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009