Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)
Advanced Gastric Cancer
About this trial
This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Gastric cancer,, advanced gastric cancer,, stomach neoplasm,, stomach disease,, adenocarcinoma of stomach,, GI neoplasm
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
- Loma Linda Oncology Medical Group Loma Linda
- Henry Ford Hospital Dept. of Henry Ford Hospital
- University of Minnesota Cancer Center
- University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)
- The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
- University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
- University of Washington Cancer Care Seattle Cancer Alliance
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Everolimus + BSC
Placebo + BSC
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.