Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2009 |
| End Date: | January 2014 |
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
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.
with advanced gastric cancer which has progressed after one or two lines of prior
chemotherapy.
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
We found this trial at
9
sites
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