Back to resultsEfficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
Primary Purpose
Advanced Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Gastric Cancer, RAD001, mTOR
Eligibility 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
Sites / Locations
- Novartis investigative Site
- Novartis investigative Site
- Novartis investigative Site
- Novartis Investigative Site
- Novartis investigative Site
- Novartis investigative Site
- Novartis Investigative Site
- Novartis investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RAD001
Arm Description
Outcomes
Primary Outcome Measures
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Secondary Outcome Measures
Objective response rate (ORR) assessed by RECIST criteria
To assess progression free survival (PFS) and overall survival (OS)
To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0
Full Information
NCT ID
NCT00519324
First Posted
August 21, 2007
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00519324
Brief Title
Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
Gastric Cancer, RAD001, mTOR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RAD001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
10 mg/day (2 tablets of 5 mg each)
Primary Outcome Measure Information:
Title
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) assessed by RECIST criteria
Time Frame
18 months
Title
To assess progression free survival (PFS) and overall survival (OS)
Time Frame
18 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis investigative Site
City
Aichi
Country
Japan
Facility Name
Novartis investigative Site
City
Chiba
Country
Japan
Facility Name
Novartis investigative Site
City
Ehime
Country
Japan
Facility Name
Novartis Investigative Site
City
Hokkaido
Country
Japan
Facility Name
Novartis investigative Site
City
Osaka
Country
Japan
Facility Name
Novartis investigative Site
City
Shizuoka
Country
Japan
Facility Name
Novartis Investigative Site
City
Tochigi
Country
Japan
Facility Name
Novartis investigative Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20231677
Citation
Doi T, Muro K, Boku N, Yamada Y, Nishina T, Takiuchi H, Komatsu Y, Hamamoto Y, Ohno N, Fujita Y, Robson M, Ohtsu A. Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. J Clin Oncol. 2010 Apr 10;28(11):1904-10. doi: 10.1200/JCO.2009.26.2923. Epub 2010 Mar 15.
Results Reference
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Learn more about this trial
Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
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