Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
NCT ID: NCT00519324
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAD001
Everolimus
10 mg/day (2 tablets of 5 mg each)
Interventions
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Everolimus
10 mg/day (2 tablets of 5 mg each)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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References
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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.
Other Identifiers
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CRAD001C1201
Identifier Type: -
Identifier Source: org_study_id