Clinical trial · Interventional
Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment
NCT00519324CI-TRIAL-00024822completedPhase 2ClinicalTrials.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)
The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
- timeFrame
- 18 months
Secondary outcomes (3)
- measure
- Objective response rate (ORR) assessed by RECIST criteria
- timeFrame
- 18 months
- measure
- To assess progression free survival (PFS) and overall survival (OS)
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: * Histological proven gastric adenocarcinoma * 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: * History of another primary malignancy within 3 years * 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 Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- RESULTDoi 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. PMID 20231677