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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00813605

Public ClinicalTrials.gov record NCT00813605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT00813605
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
NantCell, Inc.
Industry
Enrollment
155 participants

Conditions and interventions

Interventions

Other · Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2009 (Type not available)
Primary completion
Jan 2011 (Actual)
Completion
Jun 2012 (Actual)
Last update posted
Oct 27, 2016

2009 – 2012

United States locations

U.S. sites
28
U.S. states
16
U.S. cities
26
Facility City State ZIP Site status
Research Site Beverly Hills California 90211 —
Research Site Los Angeles California 90095 —
Research Site Santa Maria California 93454 —
Research Site Denver Colorado 80218 —
Research Site Denver Colorado 80220 —
Research Site Miami Florida 33136 —
Research Site Ocala Florida 34471 —
Research Site Port Saint Lucie Florida 34952 —
Research Site Atlanta Georgia 30341 —
Research Site Chicago Illinois 60637 —
Research Site Joliet Illinois 60435 —
Research Site Fishers Indiana 46037 —
Research Site Wichita Kansas 67214 —
Research Site Paducah Kentucky 42003 —
Research Site Worcester Massachusetts 01655 —
Research Site Lebanon New Hampshire 03756 —
Research Site Hudson New York 12534 —
Research Site New York New York 10032 —
Research Site High Point North Carolina 27262 —
Research Site Columbus Ohio 43235 —
Research Site Philadelphia Pennsylvania 19106 —
Research Site Philadelphia Pennsylvania 19107 —
Research Site Amarillo Texas 79106 —
Research Site Austin Texas 78731 —
Research Site Dallas Texas 75231 —
Research Site Temple Texas 76508 —
Research Site Tyler Texas 75702 —
Research Site Roanoke Virginia 24014 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00813605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 27, 2016 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00813605 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →