Metastatic Colorectal CancerPhase 2NCT00813605
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 study testing FOLFIRI, AMG 655 and AMG 479 in people with Metastatic Colorectal Cancer, run by NantCell, Inc. at 67 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- FOLFIRI, AMG 655 and AMG 479
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 67 sitesin 10 countries
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
67 sites in 10 countries.
67 sites in 10 countries
United States28 sites
Research Site
Amarillo, Texas, 79106
Research Site
Atlanta, Georgia, 30341
Research Site
Austin, Texas, 78731
Research Site
Beverly Hills, California, 90211
Research Site
Chicago, Illinois, 60637
Research Site
Columbus, Ohio, 43235
Research Site
Dallas, Texas, 75231
Research Site
Denver, Colorado, 80218
Research Site
Denver, Colorado, 80220
Research Site
Fishers, Indiana, 46037
Research Site
High Point, North Carolina, 27262
Research Site
Hudson, New York, 12534
Research Site
Joliet, Illinois, 60435
Research Site
Lebanon, New Hampshire, 03756
Research Site
Los Angeles, California, 90095
Research Site
Miami, Florida, 33136
Research Site
New York, New York, 10032
Research Site
Ocala, Florida, 34471
Research Site
Paducah, Kentucky, 42003
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Port Saint Lucie, Florida, 34952
Research Site
Roanoke, Virginia, 24014
Research Site
Santa Maria, California, 93454
Research Site
Temple, Texas, 76508
Research Site
Tyler, Texas, 75702
Research Site
Wichita, Kansas, 67214
Research Site
Worcester, Massachusetts, 01655
Russia8 sites
Research Site
Arkhangelsk, 163045
Research Site
Kursk, 305035
Research Site
Moscow, 115478
Research Site
Obninsk, 249036
Research Site
Saint Petersburg, 191104
Research Site
Saint Petersburg, 197089
Research Site
Samara, 443031
Research Site
Ufa, 450054
India7 sites
Research Site
Bangalore, 560 029
Research Site
Hyderabad, Andhra Pradesh, 500 082
Research Site
Kolkata, West Bengal, 700 016
Research Site
Mumbai, Maharashtra, 400 012
Research Site
Nagpur, Maharashtra, 440 012
Research Site
Nashik, Maharashtra, 422 005
Research Site
Pune, Maharashtra, 411 004
Spain6 sites
Research Site
Barcelona, Cataluña, 08035
Research Site
Barcelona, Cataluña, 08036
Research Site
L'Hospitalet de Llobregat, Cataluña, 08907
Research Site
Madrid, Madrid, 28040
Research Site
Madrid, Madrid, 28041
Research Site
Pamplona, Navarre, 31008
France4 sites
Research Site
Bordeaux, 33076
Research Site
Boulogne-Billancourt, 92100
Research Site
Lille, 59020
Research Site
Lyon, 69373
Hungary4 sites
Research Site
Budapest, 1097
Research Site
Győr, 9023
Research Site
Pécs, 7624
Research Site
Szeged, 6720
Italy3 sites
Research Site
Genova, 16132
Research Site
Milan, 20142
Research Site
Orbassano, 10043
Poland3 sites
Research Site
Gdansk, 80-952
Research Site
Gliwice, 44-101
Research Site
Opole, 45-060
Singapore3 sites
Research Site
Singapore, 119228
Research Site
Singapore, 169610
Research Site
Singapore, 308433
About this study
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
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
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- FOLFIRI, AMG 655, Placebo, AMG 479
- 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
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasm Metastasis, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRIOther
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 655Biological
Also called Conatumumab
AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5)
PlaceboOther
Inactive dummy agent (to maintain blind)
AMG 479Biological
AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days Receives: Other: FOLFIRI; Biological: AMG 655; Other: Placebo |
| Arm C | Active comparator | AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days Receives: Other: FOLFIRI; Other: Placebo |
| Arm B | Experimental | AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days Receives: Other: FOLFIRI; Other: Placebo; Biological: AMG 479 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Length of Study
Secondary outcomes (4)
Overall Survival, Objective Response, Duration of Response, Time to Response
Measured: Length of Study
Incidence of adverse events
Measured: Length of Study
Significant laboratory abnormalities
Measured: Length of Study
Incidence of antibody formation
Measured: Length of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813605
- Sponsor's protocol ID
- 20060579
- Other IDs
- QUILT-2.018
- Status last verified
- Oct 2016
- First submitted
- 22 Dec 2008
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00813605
- Acronym / sponsor ID
- 20060579
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- AMG 655, AMG 479, Colon Cancer, Rectal Cancer, Monoclonal Antibody, Clinical Trial, Colorectal Cancer, metastatic colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- NantCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: FOLFIRI, Biological: AMG 655, Other: PlaceboAMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days |
| Arm C | Active comparator | Other: FOLFIRI, Other: PlaceboAMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days |
| Arm B | Experimental | Other: FOLFIRI, Other: Placebo, Biological: AMG 479AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRIDay 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 | Other | Arm A, Arm B, Arm C |
| AMG 655Also: ConatumumabAMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5) | Biological | Arm A |
| PlaceboInactive dummy agent (to maintain blind) | Other | Arm A, Arm B, Arm C |
| AMG 479AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1 | Biological | Arm B |
Primary outcome
Progression Free Survival
Time frame: Length of Study
4 secondary outcomes
Overall Survival, Objective Response, Duration of Response, Time to Response
Time frame: Length of Study
Incidence of adverse events
Time frame: Length of Study
Significant laboratory abnormalities
Time frame: Length of Study
Incidence of antibody formation
Time frame: Length of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
67 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFIRI, AMG 655 and AMG 479 in people with Metastatic Colorectal Cancer, run by NantCell, Inc. at 67 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Russia, India, Spain, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Length of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.