CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 800 enrolled
Drug / intervention
AMG 479 +3 moredrug
Likely dose
AMG 479 12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01231347
NCT01231347Phase 3Completed
CompareCT.gov

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

NantCell, Inc.·interventional·Posted Nov 1, 2010·Updated Jul 16, 2024

In Brief

A Phase 3 clinical trial evaluating AMG 479, Placebo, and 1 other intervention for Adenocarcinoma of the Pancreas and 15 related conditions. Completed, enrolled 800 participants across 152 sites in 32 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Pancreas, Advanced Solid Tumors, Cancer, Cancer of Pancreas, Cancer of the Pancreas, Metastases, Metastatic Cancer, Metastatic Pancreatic Cancer, Pancreas Cancer, Pancreatic Cancer, Bone Metastases, Endocrine Cancer, Oncology, Oncology Patients, Solid Tumors, Advanced Malignancy
CountriesAustralia, 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, United States
CollaboratorsTakeda

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartApr 7, 2011
Primary CompletionDec 12, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.7 years ago

Interventions

AMG 479drug

AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

Placebodrug

Placebo administered intravenously on days 1 and 15 of a 28 day cycle

AMG 479drug

AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle

gemcitabinedrug

gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle