A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATION WITH 5 FLUOROURACIL, FOLINIC ACID, AND OXALIPLATIN (mFOLFOX6) IN PATIENTS WITH METASTATIC HER2 NEGATIVE, MET-POSITIVE GASTROESOPHAGEAL CANCER

Not available

Registry ID

EUCTR2012-001402-23

Source registry

EUCTR

Status

Prematurely Ended

Phase

PHASE3

Sponsor

F. Hoffmann-La Roche Ltd.

Start date

2013-03-26

Completion date

2015-12-01

Last update

2026-08-16

Conditions

• GASTROESOPHAGEAL CANCER

Summary

• To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by overall survival (OS) in patients with previously untreated HER2–negative metastatic gastroesophageal cancer (GEC) classified as Met IHC 2+ or 3+ (Met 2+/3+ subgroup) • To evaluate the efficacy of onartuzumab + mFOLFOX6 compared with placebo + mFOLFOX6 as measured by OS in patients with previously untreated HER2 negative metastatic GEC classified as Met-IHC 1+, 2+, or 3+ (intent-to-treat [ITT] population)

Locations

• , , Italy
• , , UK
• , , Belgium
• , , Spain
• , , Germany
• , , Czechia
• , , Poland

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