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

Status:	Completed
Conditions:	Colorectal Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	March 2009
End Date:	June 2012

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

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

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of colon or rectum in patients with
metastatic disease

- Mutant-type KRAS tumor at screening

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1

- Adequate hematology, renal, hepatic, and coagulation function

Exclusion Criteria:

- History or known presence of central nervous system metastases

- History of other malignancy

- Prior irinotecan-based chemotherapy for advanced/metastatic disease

- Prior death receptor agonists, or other systemic IGF-1R agonists in any setting

- Uncontrolled cardiovascular disease

We found this trial at

sites

Clinical Trial Facility in New York New York

New York, New York 10032

from

New York, NY