RAD001 (Everolimus) Salvage Monotherapy in Advanced Gastric Cancer (AGC) Who Failed Standard First-line Treatment
This is a phase II study to evaluate RAD001 (Everolimus) in terms of 4-month progression-free survival rate (primary end-point) and response rate, toxicity, and overall survival (secondary end-points) in patients with metastatic and/or advanced inoperable gastric cancer.
Eligibility criteria include histologically proven gastric/gastroesophageal junction cancer who failed previous first-line standard treatment with fluoropyrimidine and platinum-based chemotherapy.
Oral RAD001 (everolimus) 10mg daily will be administered and the dose will be adjusted according to the observed clinical toxicities. Treatment will be continued until disease progression or patient's intolerability to the study drug.
Total of 54 patients will be enrolled to decide whether the proportion of patients who are free from progression at 4 months (16 weeks), P, is less that or equal to 0.15 or greater than or equal to 0.30 to assess the treatment outcome in 48 patients assuming drop-out rate, 10%.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of RAD001 (Everolimus) in Patients With Fluoropyrimidine and Platinum-refractory Advanced Gastric Cancer|
- progression-free survival rate at 4-month (16 weeks) [ Time Frame: 4 months (16 weeks) ] [ Designated as safety issue: No ]
- response rate [ Time Frame: 2years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity profiles (according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Treatment Arm (RAD001)
RAD001 (everolimus) 10mg daily administration orally until disease progression and/or intolerability
Other Name: everolimus