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 prior systemic chemotherapy

ovartis Pharma Services AG0 sites633 target enrollmentJuly 2, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 2, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male or female patients \= 18 years old
•Histologically or cytologically confirmed and documented gastric adenocarcinoma. Patients with advanced gastro\-esophageal junction adenocarcinoma, of which at least 50% involves the stomach, will be eligible for inclusion in the study.
•Documented progression after 1 or 2 prior systemic chemotherapy treatments for advanced disease
•Note: Prior adjuvant/neoadjuvant therapy is allowed. If recurrence occurred during adjuvant/neoadjuvant therapy or \= 24 weeks after adjuvant/neoadjuvant therapy completion, the adjuvant/neoadjuvant therapy will be considered as one prior regimen of systemic chemotherapy for advanced disease
•ECOG performance status of \= 2
•Patients with the following laboratory parameters can be included:
•o Absolute neutrophil count \= 1\.5 x 109/L (\= 1500/mm3\)
•o Platelets \= 100 x 109/L (\= 100,000/mm3\)
•o Hemoglobin (Hgb) \= 8 g/dL (\= 4\.9 mmol/L)
•o INR \= 2\.0

•Patients who have received \> 2 prior systemic therapies for advanced disease
•Note: If recurrence occurred during adjuvant/neoadjuvant therapy or \= 24 weeks after adjuvant/neoadjuvant therapy completion, the adjuvant/neoadjuvant therapy will be considered as one prior regimen of systemic chemotherapy for advanced disease
•Administration of anti\-cancer therapy within 3 weeks prior to randomization, except for fluoropyrimidine monotherapy, where randomization may occur 2 weeks after last dose.
•Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g., sirolimus, temsirolimus)
•Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
•Major surgery \= 2 weeks prior to randomization
•Note: Patients must have recovered from the acute effects of surgery prior to randomization.
•Malignant ascites requiring invasive treatment (such as ascites drainage)
•Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade \= 1
•Patients with central nervous system metastases