RAD001 in Advanced Gastric Cancer Who Failed Standard First-line Treatment With pS6 Ser 240/4 Expression
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
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, overall survival and biomarker
assessment (secondary end-points) in patients with metastatic or recurrent gastric cancer
with pS6 Ser 240/4 expression.
Eligibility criteria include pathologically proven non-resectable adenocarcinoma of stomach
with measurable disease who failed previous first-line palliative chemotherapy including
fluoropyrimidine and platinum with high expression of pS6 Ser 240/4.
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.
A study requires 40 assessable subjects to decide whether the proportion of patients who are
free from progression at 4 months (16 weeks), P, is less than or equal to 0.1 or greater than
or equal to 0.25 with a target error rate of 0.05 and β of 0.2. If the number of responses is
7 or less, the hypothesis that P >= 0.250 is rejected with a target error rate of 0.200 and
an actual error rate of 0.182. If the investigators assume that drop-out rate is 10%, total
accrual patient will be 45.