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

March 28, 2014 updated by: Amgen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Research Site
    • California
      • 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
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • 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, 33176
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
      • Lawrenceville, Georgia, United States, 30045
        • Research Site
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Research Site
      • Maywood, Illinois, United States, 60153
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Research Site
      • Baltimore, Maryland, United States, 21215
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0995
        • Research Site
      • St. Joseph, Michigan, United States, 49085
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63136
        • Research Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Research Site
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109-4397
        • Research Site
    • New York
      • 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
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Research Site
      • Burlington, North Carolina, United States, 27215
        • Research Site
      • Gastonia, North Carolina, United States, 28054
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Research Site
      • Winston Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45226
        • Research Site
      • Columbus, Ohio, United States, 43219
        • Research Site
      • Middletown, Ohio, United States, 45042
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Research Site
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17109
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Pottsville, Pennsylvania, United States, 17901
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • 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
        • Research Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Research Site
      • Richmond, Virginia, United States, 23235
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site
      • Vancouver, Washington, United States, 98684
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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: 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 Names:
  • 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).
Drug: Placebo
Inactive dummy AMG 655 (to maintain blind)
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 Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Length of study
Length of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Length of study
Length of study
Objective response rate
Time Frame: Length of study
Length of study
Duration of response
Time Frame: Length of study
Length of study
Time-to-response
Time Frame: Length of study
Length of study
AMG 655 pharmacokinetic parameters
Time Frame: Length of study
Length of study
The incidence of anti-AMG 655 antibody formation
Time Frame: Length of study
Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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