Clinical trial · Interventional
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
NCT00879333CI-TRIAL-00019683GRANITE-1completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care (BSC) | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
| Everolimus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Everolimus + BSC
- description
- 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.
- interventionNames
- Drug: Everolimus
- Drug: Best Supportive Care (BSC)
- type
- PLACEBO_COMPARATOR
- label
- Placebo + BSC
- description
- 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.
- interventionNames
- Drug: Everolimus placebo
- Drug: Best Supportive Care (BSC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOhtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16. PMID 24043745