- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519324
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
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
-
-
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Aichi, Japan
- Novartis Investigative Site
-
Chiba, Japan
- Novartis Investigative Site
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Ehime, Japan
- Novartis Investigative Site
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Hokkaido, Japan
- Novartis Investigative Site
-
Osaka, Japan
- Novartis Investigative Site
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Shizuoka, Japan
- Novartis Investigative Site
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Tochigi, Japan
- Novartis Investigative Site
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Tokyo, Japan
- Novartis Investigative Site
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-
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
|
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
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.
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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