Phase 3
N=656
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Advanced Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00879333 ↗Enrolled (actual)
656
Serious AEs
45.9%
Results posted
Apr 2015
Primary outcome: Primary: Overall Survival (OS) — 5.39; 4.34 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Everolimus (Drug); Everolimus placebo (Drug); Best Supportive Care (BSC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.39; 4.34 | — |
| SECONDARY Progression Free Survival (PFS) |
1.68; 1.41 | — |
| SECONDARY Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores |
1.51; 1.45; 1.35; 1.15; 1.87; 1.87 | — |
| SECONDARY Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score |
2.30; 2.23 | — |
| SECONDARY Overall Response Rate (ORR) |
379; 191; 1; 0; 16; 4 | — |
| SECONDARY Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5 |
16.143; 10.498; 72.775; 37.269 | — |
| SECONDARY Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5 |
16.804; 9.921; 73.568; 34.580; 15.009; 11.406 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT00879333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.