Back to resultsQUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FOLFIRI
AMG 655
Placebo
AMG 479
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring AMG 655, AMG 479, Colon Cancer, Rectal Cancer, Monoclonal Antibody, Clinical Trial, Colorectal Cancer, metastatic colorectal cancer, metastatic cancer, antibody-2nd line, KRAS, adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Arm A
Arm C
Arm B
Arm Description
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Overall Survival, Objective Response, Duration of Response, Time to Response
Incidence of adverse events
Significant laboratory abnormalities
Incidence of antibody formation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00813605
Brief Title
QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NantCell, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
AMG 655, AMG 479, Colon Cancer, Rectal Cancer, Monoclonal Antibody, Clinical Trial, Colorectal Cancer, metastatic colorectal cancer, metastatic cancer, antibody-2nd line, KRAS, adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
Arm Title
Arm B
Arm Type
Experimental
Arm Description
AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days
Intervention Type
Other
Intervention Name(s)
FOLFIRI
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
AMG 655
Other Intervention Name(s)
Conatumumab
Intervention Description
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive dummy agent (to maintain blind)
Intervention Type
Biological
Intervention Name(s)
AMG 479
Intervention Description
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
Length of Study
Secondary Outcome Measure Information:
Title
Overall Survival, Objective Response, Duration of Response, Time to Response
Time Frame
Length of Study
Title
Incidence of adverse events
Time Frame
Length of Study
Title
Significant laboratory abnormalities
Time Frame
Length of Study
Title
Incidence of antibody formation
Time Frame
Length of Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Research Site
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Research Site
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Research Site
City
Hudson
State/Province
New York
ZIP/Postal Code
12534
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Research Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Research Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Research Site
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Research Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 082
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 012
Country
India
Facility Name
Research Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 005
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Research Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 016
Country
India
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560 029
Country
India
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
Research Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Research Site
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Research Site
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
We'll reach out to this number within 24 hrs