Metastatic Colorectal CancerPhase 1/2NCT00625651
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
A Phase 1/2 study testing AMG 655, Modified FOLFOX6 and Bevacizumab in people with Metastatic Colorectal Cancer and Colon Cancer, run by Amgen at 61 sites in United States.
Trial summary
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Colon Cancer, Colorectal Cancer
- What is being tested?
- AMG 655, Modified FOLFOX6 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 61 sitesUnited States
- Study dates
- Oct 2007to Sep 2011
- Phase
- Phase 1/2
- 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 or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Subjects with measurable or unmeasurable disease
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women at least 18 years of age
- Adequate hematologic, renal, hepatic and coagulation function
Who cannot join
- History or known presence of central nervous system (CNS) metastases
- Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
- Any investigational agent or therapy for advanced or metastatic CRC
- Clinically significant cardiac disease
- Clinically significant peripheral neuropathy
- Active inflammatory bowel disease
Show all 10Show fewer
- Recent gastrointestinal ulcer or hemorrhage
- Recent arterial thrombotic event or pulmonary embolus
- Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
- Recent major surgical procedure or not yet recovered from major surgery
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
United States61 sites
Research Site
Albuquerque, New Mexico, 87109-4397
Research Site
Ann Arbor, Michigan, 48106-0995
Research Site
Asheville, North Carolina, 28801
Research Site
Atlanta, Georgia, 30309
Research Site
Austin, Texas, 78731
Research Site
Baltimore, Maryland, 21215
Research Site
Baltimore, Maryland, 21237
Research Site
Boca Raton, Florida, 33486
Research Site
Boston, Massachusetts, 02115
Research Site
Buffalo, New York, 14263
Research Site
Burlington, North Carolina, 27215
Research Site
Cincinnati, Ohio, 45226
Research Site
Columbus, Ohio, 43219
Research Site
Denver, Colorado, 80218
Research Site
Downey, California, 90241
Research Site
Fairfax, Virginia, 22031
Research Site
Gastonia, North Carolina, 28054
Research Site
Great Falls, Montana, 59405
Research Site
Greenville, South Carolina, 29605
Research Site
Harrisburg, Pennsylvania, 17109
Research Site
Harvey, Illinois, 60426
Research Site
Hot Springs, Arkansas, 71913
Research Site
Hudson, New York, 12534
Research Site
Indianapolis, Indiana, 46227
Research Site
Kissimmee, Florida, 34741
Research Site
La Jolla, California, 92093-0957
Research Site
Lawrenceville, Georgia, 30045
Research Site
Leesburg, Florida, 34788
Research Site
Loma Linda, California, 92354
Research Site
Long Branch, New Jersey, 07740
Research Site
Louisville, Kentucky, 40202
Research Site
Maywood, Illinois, 60153
Research Site
Memphis, Tennessee, 38120
Research Site
Miami, Florida, 33136
Research Site
Miami, Florida, 33176
Research Site
Middletown, Ohio, 45042
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10021
Research Site
Newark, Delaware, 19718
Research Site
Norfolk, Virginia, 23502
Research Site
Ogden, Utah, 84403
Research Site
Orange, California, 92868
Research Site
Overland Park, Kansas, 66210
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Portland, Oregon, 97227
Research Site
Pottsville, Pennsylvania, 17901
Research Site
Raleigh, North Carolina, 27607
Research Site
Rancho Mirage, California, 92270
Research Site
Richardson, Texas, 75080
Research Site
Richmond, Virginia, 23235
Research Site
Rochester, Minnesota, 55905
Research Site
Saint Joseph, Michigan, 49085
Research Site
San Diego, California, 92123
Research Site
St Louis, Missouri, 63136
Research Site
Tacoma, Washington, 98405
Research Site
The Bronx, New York, 10469
Research Site
Tyler, Texas, 75702
Research Site
Vancouver, Washington, 98684
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Wichita Falls, Texas, 76310
Research Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
- Being tested
- Placebo, AMG 655, Modified FOLFOX6, Bevacizumab
- Keywords
- Colon Cancer, Colorectal Cancer, Rectal Cancer, AMG 655, Bevacizumab, Modified FOLFOX6, mFOLFOX6, FOLFOX
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Inactive dummy AMG 655 (to maintain blind)
AMG 655Drug
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Modified FOLFOX6Drug
Also called mFOLFOX6
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
BevacizumabDrug
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
| Study group | Role | What they receive |
|---|---|---|
| AMG 655 Low Dose | Experimental | AMG 655 (low dose) + mFOLFOX6 + Bevacizumab Receives: Drug: AMG 655; Drug: Modified FOLFOX6; Drug: Bevacizumab |
| Placebo | Placebo comparator | Placebo + mFOLFOX6 + Bevacizumab Receives: Drug: Placebo; Drug: Modified FOLFOX6; Drug: Bevacizumab |
| AMG 655 High Dose | Experimental | AMG 655 (high dose) + mFOLFOX6 + Bevacizumab Receives: Drug: AMG 655; Drug: Modified FOLFOX6; Drug: Bevacizumab |
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 (6)
Objective response rate
Measured: Length of study
Duration of response
Measured: Length of study
Time-to-response
Measured: Length of study
Overall survival
Measured: Length of study
AMG 655 pharmacokinetic parameters
Measured: Length of study
The incidence of anti-AMG 655 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 posted28 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625651
- Sponsor's protocol ID
- 20060464
- Status last verified
- Mar 2014
- First submitted
- 14 Feb 2008
- Last updated
- 25 Apr 2014
- Results posted
- No
Publications
Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.
PubMed 24122767
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00625651
- Acronym / sponsor ID
- 20060464
- Keywords
- Colon Cancer, Colorectal Cancer, Rectal Cancer, AMG 655, Bevacizumab, Modified FOLFOX6, mFOLFOX6, FOLFOX
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Feb 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 phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMG 655 Low Dose | Experimental | Drug: AMG 655, Drug: Modified FOLFOX6, Drug: BevacizumabAMG 655 (low dose) + mFOLFOX6 + Bevacizumab |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Modified FOLFOX6, Drug: BevacizumabPlacebo + mFOLFOX6 + Bevacizumab |
| AMG 655 High Dose | Experimental | Drug: AMG 655, Drug: Modified FOLFOX6, Drug: BevacizumabAMG 655 (high dose) + mFOLFOX6 + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Subjects with measurable or unmeasurable disease
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women at least 18 years of age
- Adequate hematologic, renal, hepatic and coagulation function
Key exclusion criteria (10 listed)
- History or known presence of central nervous system (CNS) metastases
- Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
- Any investigational agent or therapy for advanced or metastatic CRC
- Clinically significant cardiac disease
- Clinically significant peripheral neuropathy
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 |
|---|---|---|
| PlaceboInactive dummy AMG 655 (to maintain blind) | Drug | Placebo |
| AMG 655AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5). | Drug | AMG 655 High Dose, AMG 655 Low Dose |
| Modified FOLFOX6Also: mFOLFOX6Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days) | Drug | AMG 655 High Dose, AMG 655 Low Dose, Placebo |
| BevacizumabBevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days). | Drug | AMG 655 High Dose, AMG 655 Low Dose, Placebo |
Primary outcome
Progression-free survival
Time frame: Length of study
6 secondary outcomes
Objective response rate
Time frame: Length of study
Duration of response
Time frame: Length of study
Time-to-response
Time frame: Length of study
Overall survival
Time frame: Length of study
AMG 655 pharmacokinetic parameters
Time frame: Length of study
The incidence of anti-AMG 655 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 25 Apr 2014.
- Background: PubMed 24122767Fuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1.
- 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
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMG 655, Modified FOLFOX6 and Bevacizumab in people with Metastatic Colorectal Cancer and Colon Cancer, run by Amgen at 61 sites in United States.
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 5 inclusion and 10 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
On the ClinicalTrials.gov record for NCT00625651, which also lists 1 linked publication.
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 25 Apr 2014.