QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
Completed · Phase 2 · Has a placebo group
Conditions studied: Metastatic Colorectal Cancer
In brief
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
Key facts
- Study ID
- NCT00813605
- Run by
- NantCell, Inc.
- People needed
- 155
- Starts
- 2009-03-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2016-10-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Los Angeles, California, United States
- Research Site — Santa Maria, California, United States
- Research Site — Denver, Colorado, United States
- Research Site — Denver, Colorado, United States
- Research Site — Miami, Florida, United States
- Research Site — Ocala, Florida, United States
- Research Site — Port Saint Lucie, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Joliet, Illinois, United States
- Research Site — Fishers, Indiana, United States
- Research Site — Wichita, Kansas, United States
- Research Site — Paducah, Kentucky, United States
- Research Site — Worcester, Massachusetts, United States
- Research Site — Lebanon, New Hampshire, United States
- Research Site — Hudson, New York, United States
- Research Site — New York, New York, United States
- Research Site — High Point, North Carolina, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Amarillo, Texas, United States
- Research Site — Austin, Texas, United States
- Research Site — Dallas, Texas, United States
- Research Site — Beverly Hills, California, United States
Full record on ClinicalTrials.gov
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