NCT00813605

QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	FOLFIRI	Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion
BIOLOGICAL	AMG 655	AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
OTHER	Placebo	Inactive dummy agent (to maintain blind)
BIOLOGICAL	AMG 479	AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-01-01
• Completion: 2012-06-01
• First posted: 2008-12-23
• Last updated: 2016-10-27

Locations

67 sites across 10 countries: United States, France, Hong Kong, Hungary, India, Italy, Poland, Russia, Singapore, Spain