drugset / Trial / NCT01472198

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

NCT01472198

Phase 2 Completed 250 enrolled Gilead Sciences
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Simtuzumab Monoclonal antibody 200 mg Intravenous
Subject Simtuzumab Monoclonal antibody 700 mg Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous