Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Randomized, double-blind, placebo-controlled, multicenter Phase-II study.
Approximately 120 subjects with CR/PR/SD after platinum compounds and fluoropyrimidines based
regimens: up to 6 cycles of cisplatin and 5-fluorouracil or capecitabine, up to 12 cycles of
FOLFOX, up to 8 cycles of XELOX, will be randomly assigned (1:1 ratio) to one of the
following treatment groups:
Arm A: Placebo 4 tablets once daily on day 1-21, every 4 weeks, until intolerance or
progression disease Arm B: Regorafenib 160 mg, 4 tablets once daily on days 1-21, every 4
weeks, until intolerance or progression disease Primary Variable: PFS1