Status:
COMPLETED
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
Eligibility Criteria
Inclusion
- Male or female patients \> 18 years old
- Histologically or cytologically confirmed and documented gastric adenocarcinoma
- Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
- ECOG Performance Status of \< 2
- Lab parameters within specifically defined intervals
- Able to provide written informed consent
Exclusion
- Patients who have received \> 2 prior systemic therapies for advanced disease
- Administration of another anticancer therapy within 3 weeks prior to randomization
- Chronic treatment with steroids or another immunosuppressive agent
- Major surgery within 2 weeks prior to randomization
- Patients with CNS metastases
- Any other severe and/or uncontrolled medical condition
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT00879333
Start Date
July 1 2009
End Date
January 1 2014
Last Update
November 3 2015
Active Locations (122)
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1
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, United States, 72703
2
Loma Linda Oncology Medical Group Loma Linda
Redlands, California, United States, 92374
3
Henry Ford Hospital Dept. of Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689
4
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455