A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Phase 2 Completed 144 enrolled Amgen

RandomizedParallel-groupTriple-blindTreatment

Summary

This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.

Timeline

Start: 2008-11
Primary completion: 2010-09
Completion: 2012-06

Publications

Peeters M, Strickland AH, Lichinitser M, Suresh AV, Manikhas G, Shapiro J, Rogowski W, Huang X, Wu B, Warner D, Jain R, Tebbutt NC. A randomised, double-blind, placebo-controlled phase 2 study of trebananib (AMG 386) in combination with FOLFIRI in patients with previously treated metastatic colorectal carcinoma. Br J Cancer. 2013 Feb 19;108(3):503-11. doi: 10.1038/bjc.2012.594. Epub 2013 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Trebananib	Peptide	10 mg/kg	—
Background	Irinotecan	Small molecule	180 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Summary

Timeline

Publications

Drugs

Indications