A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Summary

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

Timeline

Start

2011-11

Primary completion

2013-10

Completion

2015-02

Outcome

Missed primary endpoint

paper the median PFS was 3.7 months (adjusted hazard ratio [HR], 95% confidence interval [CI], p value vs placebo: 1.09 [0.74-1.61]; p = .73) PMID 28246206 ↗

paper The addition of simtuzumab to gemcitabine does not improve clinical outcomes in patients with metastatic pancreatic adenocarcinoma PMID 28246206 ↗

Publications

• Benson AB 3rd, Wainberg ZA, Hecht JR, Vyushkov D, Dong H, Bendell J, Kudrik F. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab or Placebo in Combination with Gemcitabine for the First-Line Treatment of Pancreatic Adenocarcinoma. Oncologist. 2017 Mar;22(3):241-e15. doi: 10.1634/theoncologist.2017-0024. Epub 2017 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simtuzumab	Monoclonal antibody	200 mg	Intravenous
Subject	Simtuzumab	Monoclonal antibody	700 mg	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications