A Phase II Trial of RAD001 (Everolimus) for 2nd Line Treatment After Failure of Fluoropyrimidine Plus Platinum Chemotherapy in Patients With Metastatic or Recurrent Gastric Cancer With pS6 Ser 240/4 Expression
Methodology: Prospective, non blinded, open label, single center phase II study
Criteria for evaluation: Assessment of response will be assessed radiologically according to
RECIST criteria after completion of the two cycles. Evaluation will be by physical
examination, chest X-ray, abdomen-pelvis CT scan Safety criteria: Physical examination,
vital signs, performance status, CBC, serum chemistry, NCI CTC V.3.0
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
4-month progression-free survival
Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.
up to 3years
No
Yoon-Koo Kang, MD, PhD
Principal Investigator
Asan Medical Center
South Korea: Korea Food and Drug Administration (KFDA)
AMC1103
NCT01482299
November 2011
August 2013
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