QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
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
2 other identifiers
interventional
155
10 countries
67
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Typical duration for phase_2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 27, 2016
October 1, 2016
1.8 years
December 22, 2008
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Length of Study
Secondary Outcomes (4)
Overall Survival, Objective Response, Duration of Response, Time to Response
Length of Study
Incidence of adverse events
Length of Study
Significant laboratory abnormalities
Length of Study
Incidence of antibody formation
Length of Study
Study Arms (3)
Arm A
EXPERIMENTALAMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Arm C
ACTIVE COMPARATORAMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
Arm B
EXPERIMENTALAMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Interventions
Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NantCell, Inc.lead
Study Sites (67)
Research Site
Beverly Hills, California, 90211, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Santa Maria, California, 93454, United States
Research Site
Denver, Colorado, 80218, United States
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Denver, Colorado, 80220, United States
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Miami, Florida, 33136, United States
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Ocala, Florida, 34471, United States
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Port Saint Lucie, Florida, 34952, United States
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Atlanta, Georgia, 30341, United States
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Chicago, Illinois, 60637, United States
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Joliet, Illinois, 60435, United States
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Fishers, Indiana, 46037, United States
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Wichita, Kansas, 67214, United States
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Paducah, Kentucky, 42003, United States
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Worcester, Massachusetts, 01655, United States
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Lebanon, New Hampshire, 03756, United States
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Hudson, New York, 12534, United States
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New York, New York, 10032, United States
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High Point, North Carolina, 27262, United States
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Columbus, Ohio, 43235, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19107, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78731, United States
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Dallas, Texas, 75231, United States
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Temple, Texas, 76508, United States
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Tyler, Texas, 75702, United States
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Roanoke, Virginia, 24014, United States
Research Site
Bordeaux, 33076, France
Research Site
Boulogne-Billancourt, 92100, France
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Lille, 59020, France
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Lyon, 69373, France
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New Territories, Hong Kong
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Budapest, 1097, Hungary
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Győr, 9023, Hungary
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Pécs, 7624, Hungary
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Szeged, 6720, Hungary
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Hyderabad, Andhra Pradesh, 500 082, India
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Mumbai, Maharashtra, 400 012, India
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Nagpur, Maharashtra, 440 012, India
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Nashik, Maharashtra, 422 005, India
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Pune, Maharashtra, 411 004, India
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Kolkata, West Bengal, 700 016, India
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Bangalore, 560 029, India
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Genova, 16132, Italy
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Milan, 20142, Italy
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Orbassano, 10043, Italy
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Gdansk, 80-952, Poland
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Gliwice, 44-101, Poland
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Opole, 45-060, Poland
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Arkhangelsk, 163045, Russia
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Kursk, 305035, Russia
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Moscow, 115478, Russia
Research Site
Obninsk, 249036, Russia
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Saint Petersburg, 191104, Russia
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Saint Petersburg, 197089, Russia
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Samara, 443031, Russia
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Ufa, 450054, Russia
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Singapore, 119228, Singapore
Research Site
Singapore, 169610, Singapore
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Singapore, 308433, Singapore
Research Site
Barcelona, Cataluña, 08035, Spain
Research Site
Barcelona, Cataluña, 08036, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, 08907, Spain
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Madrid, Madrid, 28040, Spain
Research Site
Madrid, Madrid, 28041, Spain
Research Site
Pamplona, Navarre, 31008, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2008
First Posted
December 23, 2008
Study Start
March 1, 2009
Primary Completion
January 1, 2011
Study Completion
June 1, 2012
Last Updated
October 27, 2016
Record last verified: 2016-10