Trials / Completed

CompletedNCT01231347

QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 800 (actual)

Sponsor: NantCell, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Conditions

Interventions

Type	Name	Description
DRUG	AMG 479	AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
DRUG	Placebo	Placebo administered intravenously on days 1 and 15 of a 28 day cycle
DRUG	AMG 479	AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
DRUG	gemcitabine	gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle

Timeline

Start date: 2011-04-07
Primary completion: 2012-12-12
Completion: 2012-12-12
First posted: 2010-11-01
Last updated: 2024-07-16
Results posted: 2024-07-16

Locations

152 sites across 32 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Source: ClinicalTrials.gov record NCT01231347. Inclusion in this directory is not an endorsement.