NCT01472198

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

A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Simtuzumab	Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
DRUG	Gemcitabine	Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
DRUG	Placebo to match simtuzumab	Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-10-01
• Completion: 2015-02-01
• First posted: 2011-11-16
• Last updated: 2015-03-10

Locations

57 sites across 2 countries: United States, Russia