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Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00625651
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Colon Cancer Colorectal Cancer Rectal Cancer Drug: Placebo Drug: AMG 655 Drug: Modified FOLFOX6 Drug: Bevacizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

Drug: Modified FOLFOX6
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)
Other Name: mFOLFOX6

Drug: Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Placebo Comparator: Placebo
Placebo + mFOLFOX6 + Bevacizumab
Drug: Placebo
Inactive dummy AMG 655 (to maintain blind)

Drug: Modified FOLFOX6
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)
Other Name: mFOLFOX6

Drug: Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Experimental: AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

Drug: Modified FOLFOX6
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)
Other Name: mFOLFOX6

Drug: Bevacizumab
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Length of study ]
  2. Duration of response [ Time Frame: Length of study ]
  3. Time-to-response [ Time Frame: Length of study ]
  4. Overall survival [ Time Frame: Length of study ]
  5. AMG 655 pharmacokinetic parameters [ Time Frame: Length of study ]
  6. The incidence of anti-AMG 655 antibody formation [ Time Frame: Length of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625651


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Locations
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United States, Arkansas
Research Site
Hot Springs, Arkansas, United States, 71913
United States, California
Research Site
Downey, California, United States, 90241
Research Site
La Jolla, California, United States, 92093-0957
Research Site
Loma Linda, California, United States, 92354
Research Site
Orange, California, United States, 92868
Research Site
Rancho Mirage, California, United States, 92270
Research Site
San Diego, California, United States, 92123
United States, Colorado
Research Site
Denver, Colorado, United States, 80218
United States, Delaware
Research Site
Newark, Delaware, United States, 19718
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site
Boca Raton, Florida, United States, 33486
Research Site
Kissimmee, Florida, United States, 34741
Research Site
Leesburg, Florida, United States, 34788
Research Site
Miami, Florida, United States, 33136
Research Site
Miami, Florida, United States, 33176
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
Research Site
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Research Site
Harvey, Illinois, United States, 60426
Research Site
Maywood, Illinois, United States, 60153
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46227
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66210
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21215
Research Site
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48106-0995
Research Site
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63136
United States, Montana
Research Site
Great Falls, Montana, United States, 59405
United States, New Jersey
Research Site
Long Branch, New Jersey, United States, 07740
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87109-4397
United States, New York
Research Site
Bronx, New York, United States, 10469
Research Site
Buffalo, New York, United States, 14263
Research Site
Hudson, New York, United States, 12534
Research Site
New York, New York, United States, 10021
United States, North Carolina
Research Site
Asheville, North Carolina, United States, 28801
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Burlington, North Carolina, United States, 27215
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Gastonia, North Carolina, United States, 28054
Research Site
Raleigh, North Carolina, United States, 27607
Research Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45226
Research Site
Columbus, Ohio, United States, 43219
Research Site
Middletown, Ohio, United States, 45042
United States, Oregon
Research Site
Portland, Oregon, United States, 97227
United States, Pennsylvania
Research Site
Harrisburg, Pennsylvania, United States, 17109
Research Site
Philadelphia, Pennsylvania, United States, 19107
Research Site
Pottsville, Pennsylvania, United States, 17901
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38120
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Austin, Texas, United States, 78731
Research Site
Richardson, Texas, United States, 75080
Research Site
Tyler, Texas, United States, 75702
Research Site
Wichita Falls, Texas, United States, 76310
United States, Utah
Research Site
Ogden, Utah, United States, 84403
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
Research Site
Norfolk, Virginia, United States, 23502
Research Site
Richmond, Virginia, United States, 23235
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Research Site
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00625651     History of Changes
Other Study ID Numbers: 20060464
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: March 2014
Keywords provided by Amgen:
Colon Cancer
Colorectal Cancer
Rectal Cancer
AMG 655
Bevacizumab
Modified FOLFOX6
mFOLFOX6
FOLFOX
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Conatumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors