drugset / Trial / NCT01443065

MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma

NCT01443065

Phase 2 Completed 162 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

Summary

This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France. Main eligibility criteria include: histologically proven adenocarcinoma of the stomach, esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.

Timeline

Start
2011-01
Primary completion
2014-03
Completion
2018-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Subject Rilotumumab Monoclonal antibody 10 mg/kg Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous