QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
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.
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
- Enrollment
- 155 participants
Conditions and interventions
Conditions
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
- Feb 28, 2009
- Primary completion
- Dec 31, 2010
- Completion
- May 31, 2012
- Last update posted
- Oct 26, 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 26, 2016 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00813605 live on ClinicalTrials.gov.