Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00879333 | Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) | PHASE3 | COMPLETED | 656 | — | — | Jul 1, 2009 | Jan 1, 2014 | Nov 3, 2015 | 122 | United States, Argentina +20 |
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
| Arm | Type | Description |
|---|---|---|
| Everolimus + BSC | EXPERIMENTAL | 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. |
| Placebo + BSC | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Everolimus | DRUG | Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. |
| Everolimus placebo | DRUG | Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. |
| Best Supportive Care (BSC) | DRUG | Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments. |
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 specific...