Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
1 other identifier
interventional
54
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedNovember 18, 2016
November 1, 2016
1.4 years
August 21, 2007
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
18 months
Secondary Outcomes (3)
Objective response rate (ORR) assessed by RECIST criteria
18 months
To assess progression free survival (PFS) and overall survival (OS)
18 months
To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0
18 months
Study Arms (1)
RAD001
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Related Publications (1)
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.
PMID: 20231677RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 22, 2007
Study Start
August 1, 2007
Primary Completion
January 1, 2009
Last Updated
November 18, 2016
Record last verified: 2016-11