NCT01479465

Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Simtuzumab	SIM administered via intravenous infusion over 30 minutes
DRUG	Placebo to match SIM	Placebo to match SIM administered via intravenous infusion over 30 minutes
DRUG	Leucovorin	l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours
DRUG	Irinotecan	Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes
DRUG	Fluorouracil	Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-10-01
• Completion: 2015-02-01
• First posted: 2011-11-24
• Last updated: 2019-04-17
• Results posted: 2019-04-17

Locations

109 sites across 7 countries: United States, France, Germany, Italy, Poland, Russia, Spain