QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
NCT ID: NCT00813605
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2009-03-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
FOLFIRI
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
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Placebo
Inactive dummy agent (to maintain blind)
Arm C
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
FOLFIRI
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
Placebo
Inactive dummy agent (to maintain blind)
Arm B
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
FOLFIRI
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
Placebo
Inactive dummy agent (to maintain blind)
AMG 479
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FOLFIRI
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
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Placebo
Inactive dummy agent (to maintain blind)
AMG 479
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NantCell, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Beverly Hills, California, United States
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
Temple, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Roanoke, Virginia, United States
Research Site
Bordeaux, , France
Research Site
Boulogne-Billancourt, , France
Research Site
Lille, , France
Research Site
Lyon, , France
Research Site
New Territories, , Hong Kong
Research Site
Budapest, , Hungary
Research Site
Győr, , Hungary
Research Site
Pécs, , Hungary
Research Site
Szeged, , Hungary
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nagpur, Maharashtra, India
Research Site
Nashik, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Kolkata, West Bengal, India
Research Site
Bangalore, , India
Research Site
Genova, , Italy
Research Site
Milan, , Italy
Research Site
Orbassano, , Italy
Research Site
Gdansk, , Poland
Research Site
Gliwice, , Poland
Research Site
Opole, , Poland
Research Site
Arkhangelsk, , Russia
Research Site
Kursk, , Russia
Research Site
Moscow, , Russia
Research Site
Obninsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Samara, , Russia
Research Site
Ufa, , Russia
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Barcelona, Cataluña, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Pamplona, Navarre, Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QUILT-2.018
Identifier Type: OTHER
Identifier Source: secondary_id
20060579
Identifier Type: -
Identifier Source: org_study_id